Skip to main content

Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study



Urinary incontinence is a common complication among patients with prostate cancer who have undergone radical prostatectomy. Guided by social cognitive theory and a framework for the recovery of health and well-being, we propose to develop and test a self-management intervention for patients with prostate cancer who experience urinary incontinence after undergoing radical prostatectomy.


In this study, a self-management intervention for urinary incontinence (SMI-UI) is developed, comprising a mobile self-management application, a self-management handbook, and professional support. The feasibility, acceptability, and effectiveness of this intervention will be assessed. Patient data from the urology departments of two hospitals will be collected through convenience sampling by adopting an experimental, parallel, and random assignment research design. Patients experiencing urinary incontinence after undergoing radical prostatectomy will be invited to participate. After completing the pretest questionnaire, patients will be randomly divided into the experimental and attention control groups. The experimental group will undergo a 12-week SMI-UI, whereas the attention control group will receive an intervention consisting of a single dietetic education information package. The two groups will be tested 12 and 16 weeks after the pretest. In this study, we recorded the sociodemographic and clinical variables; recruitment rate; retention rate; satisfaction with the intervention; cancer-related self-efficacy; urination symptoms and disturbance; social participation and satisfaction; resilience; and demoralization.

Trial Registration ID: NCT05335967 [date of registration 04-04-2022].

Peer Review reports


Prostate cancer occurs in men, particularly at an older age. It ranks first among cancers in men in terms of incidence in 112 countries and is the leading cause of cancer-related death among men in 48 countries [1]. Radical prostatectomy is the typical method used to treat early-stage prostate cancer, and urinary incontinence is a possible complication of this surgery [2]. The primary cause of urinary incontinence is damage to the sphincter. After radical prostatectomy, most patients with prostate cancer experience varying degrees of urinary incontinence, which gradually improves over time [3]. Qualitative research has indicated that patients with prostate cancer feel despair, embarrassment, and discomfort because of urinary incontinence. The condition limits the presence of such patients in public because of anxiety about urinary incontinence and feeling uneasy about lacking urinary control [4]. Urinary leakage decreases the frequency and intensity with which these individuals engage in physical activities [5].

During disease progression, patients with prostate cancer experience anxiety, depression [6], and fear of cancer recurrence [7]. Demoralization is a major factor that predicts the deterioration of quality of life and the increase in the risks of depression and suicide among patients with cancer [8, 9]. The social adjustment of patients with prostate cancer is profoundly adversely affected during the initial 6 months after diagnosis [10]. In addition, treatment complications, such as urinary incontinence, further affect their social adjustment or participation [10, 11], cancer-related self-efficacy, demoralization [12], and resilience [13].

A self-management intervention can improve prostate cancer patients’ urinary symptoms, psychological distress [14], self-confidence in symptom management [15], and self-efficacy [16]. Various applications (apps) have also been used to assist in self-management interventions. Patients have reported that apps can provide support in symptom management [17]. Thus far, no application-assisted self-management intervention for improving the social participation and satisfaction, demoralization, and resilience of patients with prostate cancer with urinary incontinence after radical prostatectomy has been made widely available.

Application and effectiveness of a self-management intervention

Self-management is the process where patients participate in some activities with the assistance of health-care providers when they are facing health-related issues. The aim is to maintain a healthy lifestyle, assess physical and psychological status, monitor symptoms, and respond to shocks [18]. The majority of e-health-based self-management is conducted through websites, with a few interventions performed using an application. The duration of interventions is typically 4–24 weeks, with 12 weeks in most studies. All relevant studies have assessed the baseline characteristics and outcomes after the intervention at least once. Self-management interventions based on e-health can improve the self-efficacy and cancer-related fatigue of patients with cancer [19]. A systematic review suggested, but could not statistically demonstrate, that self-management interventions may improve the self-efficacy of patients with prostate cancer [16].

Social cognitive theory is most commonly used to guide studies on self-management interventions for patients with prostate cancer [14, 20, 21]. Self-management interventions can be provided to patients with prostate cancer through face-to-face interaction [14, 22, 23], websites [20, 21, 24,25,26], telephone calls [15], apps [17, 27, 28], and combined strategies [29,30,31]. Interventions typically last 4–19 weeks [14, 15, 17, 20, 21, 23,24,25,26,27, 29, 32]. Notably, some studies have involved a single time intervention [30]. In most studies, a single-group design [14, 21, 22, 24, 26, 29, 30] or two-group design [15, 20, 23, 25] has been adopted. Some studies have conducted a pretest and posttest after the intervention [14, 15, 20, 21, 23,24,25,26, 29], but others have only conducted a posttest after the intervention [17, 22, 27, 28, 30].

In some studies, a 2–3-month self-management intervention delivered through face-to-face interaction was provided to patients with prostate cancer who experienced urinary incontinence or other urinary symptoms. The findings indicated that such an intervention can improve urinary symptoms [14], urinary incontinence [23], and the emotional status [14] of patients. Other studies have shown that a self-management intervention can improve urinary incontinence [21], urinary function [21, 25], emotional disturbance/psychological well-being [21, 24, 31], and self-confidence regarding symptom management [15, 24].

Theoretical frameworks

Social cognitive theory states that individual behavior results from the continuous interaction between individual cognition, the environment, and behavioral factors [33]. This theory is frequently used in the development of interventions for behavior modification, particularly for improving self-efficacy [33, 34], which is defined as the self-confidence of individuals in their ability to complete a task or control a situation [35, 36]. Individuals’ self-efficacy can be promoted by providing an individual with a successful experience (performance accomplishments), vicarious experience, emotional arousal, or verbal persuasion [35, 37]. Patients with high self-efficacy view adversity as a challenge; they are characterized by low levels of depression and anxiety [36, 37] and high resilience [36]. The effect of self-efficacy on individuals is not limited to stressful situations. It can generate motivation in individuals and can encourage them to set challenging goals, thereby affecting their decisions and behavior.

In the framework for the recovery of health and well-being of patients with cancer, cancer-related self-efficacy is defined as the self-confidence of patients regarding their self-management of cancer and cancer-related symptoms after primary treatment [38, 39]. The diagnosis and treatment of cancer render individuals vulnerable and decrease their self-confidence. Self-confidence is the key factor that enables patients to practice self-management after cancer treatment. The reconstruction of self-confidence helps patients to manage the problems caused by cancer and its treatment, thus improving their health and well-being [39]. An individual’s cancer-related self-efficacy is strongly affected by preexisting factors (basic demographic attributes), personal factors (disease cognition, general self-efficacy), and environmental factors (social support, health services). Improving cancer-related self-efficacy can help individuals to implement self-management and to be more confident in managing their problems, thereby promoting the recovery of their health and well-being [38, 39]. Improving the self-efficacy of an individual through self-management can improve their health behavior and status [18] and well-being [39].

Specific objectives

Guided by social cognitive theory [33, 35, 37] and the framework for the recovery of health and well-being [38, 39], this study aims to develop a 12-week application-assisted self-management intervention for urinary incontinence (SMI-UI). Moreover, its feasibility, acceptability, and effects on primary outcomes (cancer-related self-efficacy) and secondary outcomes (urinary symptoms and disturbance, social participation and satisfaction, resilience, and demoralization) will be evaluated. The framework is shown in Fig. 1.


Study design and settings

This protocol follows the SPIRIT guidelines [40]. The study will use a parallel random assignment research design with an experimental group and an attention control group [41]. Patients with prostate cancer will be recruited from the urology outpatient department of two hospitals in Taiwan through convenience sampling.


The inclusion and exclusion criteria are described below. A. Inclusion criteria: (A) Patients with prostate cancer who received radical prostatectomy and suffering from urinary incontinence for at least one week (within two years after surgery). (B) Patients who agree to participate in the research and provide written informed consent. (C) Patients with Eastern Cooperative Oncology Group 0–1 point who can walk independently [42]. (D) Patients who have a smartphone or tablet with a wireless network. (E) Their intimate partner or one of the family members is willing to learn together.

B. Exclusion criteria: (A) A request, with the consideration of family members, that the medical team not tell the patient about the diagnosis or condition of the disease. (B) A history of psychiatric illness, such as dementia, depression, schizophrenia, or bipolar disorder. (C) Suffer from other types of cancer and actively undergoing treatment.

Discontinuation criteria

After the patients agree to participate in this research, the intervention will be discontinued if they meet any of the following conditions: (1) A physician determines that pelvic floor muscle exercise (PFME) is not suitable for the patient. (2) The patient meets the exclusion criteria. (3) The patient has not experienced urinary incontinence for 1 week or longer prior to the start of the intervention. (4) The patient perceives an improvement in their symptoms of urinary incontinence prior to the commencement of the study. Therefore, although they still experience episodes, they may choose not to participate in the study.

Research instruments


Feasibility is to be assessed based on the recruitment rate and retention rate. The recruitment rate is calculated as follows: [(total number of participants recruited during the study period divided by total number of hospitals)/months of duration of recruitment] [43].


Five self-designed questions will be used to determine the acceptability of the developed self-management intervention. The measures include overall satisfaction with the SMI-UI, and the effect and applicability of the intervention in improving self-management ability and self-confidence. The scores for each question range from 0 to 100, with higher scores indicating greater satisfaction.

Primary outcome variables

Cancer-related self-efficacy

The Chinese version of the self-efficacy scale for patients with cancer [12, 44, 45] will be used to determine the self-efficacy of patients with prostate cancer. It consists of 11 questions, which are scored on a scale of 1–10 points, with a total score of 11–110 points. A higher score denotes better self-efficacy in the self-management of cancer. As per nonparametric item response theory, all 11 items were confirmed to belong to one dimension. The Cronbach’s α is 0.92 for the original English version [38, 45]. The Chinese version has acceptable content validity and internal consistency [12, 44].

Secondary outcome variables

Urinary symptoms and disturbance

The Chinese version of the Expanded Prostate Cancer Index Composite (EPIC) consists of 50 questions, including several subscales (e.g., urinary, bowel, sexual, and hormonal). In the proposed study, the urinary incontinence and irritant/obstructive bladder symptoms of patients with prostate cancer will be evaluated using the urinary subscale (12 questions) [6, 46]. The score of each item will be transformed to a 0–100 point scale. Higher scores indicate fewer urinary symptoms and disturbances caused by problems with urination. The construct and criterion validity of the English version of the scale have been demonstrated. The Cronbach’s α (internal consistency) of the urinary subscale in the English version is 0.88 [46]. In the Chinese version of the scale, the Cronbach’s α at the urinary subscale is 0.79–0.89 [6]; The Chinese version has been used in relevant studies [6, 47].


The Chinese version of the 10-question Connor–Davidson Resilience Scale [48,49,50] will be adopted to measure the resilience of patients with prostate cancer. The scale comprises 10 questions with a 4-point scoring scale (0–3 points). A higher score denotes a higher degree of resilience. The Chinese version was shown to have construct validity, a Cronbach’s α of 0.94, and a 6-month test–retest reliability of 0.66 [50].


The demoralization scale (Mandarin version) will be used to measure the demoralization state of patients with prostate cancer [51, 52]. It comprises 24 questions with a 5-point scoring scale (0–4 points). A higher score denotes a higher degree of demoralization [52]. The evidence supports that the scale has criterion-related validity and discriminant validity. The Cronbach’s α value of the total scale is 0.92 [51].

Social participation

A. Chinese version of the social participation scale for elderly adults The Chinese version of the social participation scale for elderly adults will be used to measure the social participation of patients with prostate cancer. The scale comprises 12 questions in three subscales: leisure sport activities, religious beliefs, and interpersonal relationships. A 5-point scale (1–5 points) will be adopted. A higher score indicates a higher degree of social participation. The scale has construct validity and Cronbach’s α > 0.9 [53].

B. Social activity participation willingness and satisfaction items Two self-designed items will be adopted to measure the willingness and satisfaction of patients with prostate cancer to participate in social activities in the past month prior to the evaluation. The questions are “Were you willing to participate in social activities in the last month?” and “Are you satisfied with the number of times you have participated in social activities in the last month?” A Likert scale with a scoring range of 0–10 points will be used. A higher score indicates higher willingness and satisfaction to participate in social activities.

Sociodemographic and clinical variables

Basic demographic data to be collected include age, marital status, educational attainment level, religious beliefs, and occupational status. Disease characteristics include cancer stage, last serum concentration of prostate-specific antigen, history of chronic diseases, time since diagnosis (months), and treatment modalities.

Screening of individual patients and intervention-assisted questions

Question on urinary incontinence experience

A self-designed question on the experience of urinary incontinence will be used to identify patients with prostate cancer who have experienced incontinence in the past week. This question will be used to understand this experience and its severity (0–4 points) in the past week before the evaluation; “0” represents no urinary incontinence experience, whereas “4” indicates urinary leakage during a resting state, such as lying in bed.

Question on self-management confidence

Using a previous study as a reference [18], we will design a single question assessment to be administered to the experimental group after each professional support instance. The assessment aims to guage the confidence of individual patients with regards to implementation of related activities in the week following the evaluation. The assessment was based on a 0–10 point scale where “0” represents “not confident at all,” whereas “10” indicates “very confident.”


A 12-week self-management intervention for patients with urinary incontinence after radical prostatectomy will be developed based on theoretical frameworks [33, 37, 39] and literature [18, 54,55,56,57,58,59,60,61,62]. This intervention aims to promote and improve cognitive factors, environmental support, and behavioral factors (Tables 1 and 2; Fig. 1) through a mobile self-management application, a self-management handbook, and professional support. Through self-management learning, we anticipate individual patients will acquire the knowledge, skills, and self-confidence to manage their own urinary incontinence and related occurrences. Moreover, we expect patients will learn to apply this knowledge to real-life situations and achieve goals set of the intervention.

The developmental process for SMI-UI is illustrated in Fig. 2. The drafting stage involves developing multimedia content (Table 2; a new topic every two weeks for a total of six topics). The content was prepared by the principal investigator (PI) based on available literature and clinical experience. Following discussion with the research team, the content was reviewed by ten experts, including urologists, cancer case managers, nurse practitioners, psychologists, and registered nurses. The expert validity assessment with a 4-point scoring scale (1–4 points) for the six units revealed mean clarity scores ranging from 3.4 to 3.9 points and mean appropriateness scores ranging from 3.5 to 3.9 points. Content was modified based on suggestions by the experts, and thereafter multimedia films were produced. The multimedia content consists of images, animation, music, and sound. Once compiled, three patients with prostate cancer and one healthy older adult were invited to assess the initial version of the mobile self-management application, review the handbooks, view multimedia content, and offer feedback for refinement. Ultimately, revisions were made with a primary focus on improving the conciseness, clarity, and flow of the information presented in the mobile self-management application and multimedia content. The final layout and content of the handbooks received positive feedback from all four experts, and no further modifications were deemed necessary.

Mobile self-management application

The mobile self-management application (Fig. 3) developed in this study can be installed on smartphones or tablet computers. This application incorporates numerous functions, including access to multimedia information and the self-management e-handbook; recording of urinary incontinence symptoms and converting the data into a line graph; recording of PFME status and diaper usage and converting the data into line graphs; providing immediate feedback; and receiving push notifications. The application also records the reading time of the multimedia information and the self-management e-handbook for each user. If fewer than four PFME instances are recorded, the application will inform the researcher via push notification, encouraging the user to continue to meet goals (Fig. 3).

The self-management e-handbook contains the following: (A) multimedia content corresponding to the application; (B) pages for symptom recording; (C) instructions for PFME; and (D) instructions for using the mobile self-management application.

Self-management handbook

The handbook is the hard copy of the self-management e-handbook.

Professional support

Telephonic professional support will be provided weekly by a trained nurse (professional support provider), whose primary tasks involve assessing the physical and mental conditions of each patient, evaluating PFME and urinary incontinence, ensuring patient self-care, explaining the use of the application, explaining and clarifying the provided information, discussing and assisting patients with goal-setting, and performing self-confidence assessments. When providing support through communication, professional support providers will maintain a pleasant atmosphere and focus on encouraging the patients. The professional support provider can share the experiences of other patients as required. On even weeks (week 2, 4, 6, 8, 10, 12), professional support will be scheduled at a time convenient for individual patients, and on odd weeks (week 1, 3, 5, 7, 9, 11), professional support will be scheduled at a convenient time after reviewing the information. Each session will last a minimum of 5–10 min and will be tailored to the individual patient’s needs as required. The professional support provider will record the results of each session at the session’s conclusion.

Dietetic education information package

In addition to routine nursing support, individuals in the attention control group will receive a 20-min recording on a compact disc and a diet handbook for patients with prostate cancer, including an introduction, the principles of a well-balanced diet, and suggested dietary precautions. The handbook and multimedia video are a part of the multimedia psychosocial intervention developed in a previous study on the diet for patients with early prostate cancer [63].

Routine nursing

In clinical settings, the routine nursing support for patients with urinary incontinence after radical prostatectomy includes guidance on the execution of PFME, assistance in learning through biofeedback if necessary, and the provision of extracorporeal magnetic stimulation treatment and oral medicine in accordance with the condition of each patient.

Random assignment

Stratified and blocked random assignment will be utilized in this study. Three strata will be used: (A) 0–6 months, (B) 7–12 months, and (C) 13–24 months after surgery. A 2 × 2 block (block randomization) will be implemented at each level. Individual patients are to be assigned to the experimental and attention control groups at a ratio of 1:1. The random assignment code will be obtained by the principal investigator through a random number generator and will be placed in a sealed opaque envelope.

Blinded design

The attention control group is to be used to maintain internal validity [41]. Clinical health-care providers will not be informed the group assignment of the patients in this study. Health-care providers, patients, and data collectors will be unaware of the study’s hypotheses and which group is the experimental group.

Study procedure

Figures 4 and 5 present an overview of the study procedure. The urologists will refer potentially suitable cases to the researchers. Subsequently, the researchers will determine whether these patients meet the inclusion criteria by reviewing their medical records and conducting interviews based on a question regarding urinary incontinence experience. The researcher will explain the purpose and process of the study to the patients who meet the inclusion criteria and invite them to participate in this investigation. After patients agree to participate and sign the consent form, they will complete the pretest questionnaire in a private area. Next, the researcher will open the random assignment envelope prepared by the principal investigator and assign the patients to either the experimental group or the attention control group. The experimental group will undergo a 12-week SMI-UI in addition to routine care, whereas the attention control group will receive routine care and a dietetic education information package. After posttests 1 and 2, data will be collected from the two groups at 12 and 16 weeks after the pretest, respectively. With the assistance of the researchers, the mobile self-management application will be installed on the smartphones or tablets of patients in the experimental group. In accordance with the steps for the operation of the application outlined in the self-management handbook, the patients will be taught to use the application. Thereafter, the researcher will provide each patient with SMI-UI activities for a duration of 12 weeks. Patients in the attention control group will be provided with a dietetic education information pack for home learning. Face-to-face post-test 1 and post-test 2 will be scheduled during patients’ follow-up visits. In a few cases where the timing of outpatient visits are outside of data collection hours, paper questionnaires will be mailed with the patient’s consent. As a token of appreciation for their contribution to the research, participants will receive a gift voucher worth NT$100 each time they complete a questionnaire.

Management and monitoring of intervention fidelity

In this study, an Intervention Provider Handbook, a Case Interaction Record, and a research handbook will be developed. Explanatory meetings and training courses will be organized for the researchers to ensure that they clearly understand the study design, methods, processes, and relevant precautions. The SMI-UI will be performed by a trained nurse who will complete the required training before providing the intervention (intervention provider). In addition, the intervention provider will be required to complete the Case Interaction Record immediately after each session of professional support. The principal investigator will regularly review the interaction record form to assess the consistency and correctness of the provided intervention. The researcher will evaluate the time that individual patients spend reading the multimedia information and the e-handbook on the mobile self-management application and will invite patients to record the status of their urinary incontinence and the implementation frequency of PFME by using the application. The intervention provider will ask the patients some questions in each interaction to assess how they are learning about and implementing the intervention. The confidence of patients in applying new knowledge or skills to daily life will also be assessed through questions regarding self-management confidence (0–10 points). For those with a score of < 7 points, the unclear points will be clarified [18].

Ethical considerations

This study has been approved by the institutional review board of the hospital recruiting individual patients (approval number: 201902235B0C505). The research plan will be registered before initiating the recruitment of the first research case ( ID: NCT05335967). The researchers will abide by the research ethics guidelines and maintain the privacy of patients (i.e., the identity of patients will be encoded). All patients will have the right to withdraw from the study at any time with no effect on their original treatment. The collection of research data is for academic purposes only.

Data management and dissemination of results

The research data will be stored in the office of the principal investigator. The electronic files will be stored on a password-protected computer, and hard copies of the questionnaires and consent forms will be separately placed in opaque, locked cabinets. A researcher will input the questionnaire data into the IBM SPSS Statistics, and then two researchers will validate that the data have been entered correctly. Before the researchers perform statistical analysis, they will use descriptive statistics to understand the data distribution and confirm the absence of anomalous scores. The research results will be submitted to international peer-reviewed journals and conferences and provided to participants who are interested in them.

Power analysis and sample size

Cohen’s f represents a standardized measure of the average effect [64] therefore, it is not affected by the varying score ranges of each scale. Based on the results of a previous study, the effect size f is 0.27 for the outcome variable of self-efficacy [65]. The sample size of this study was estimated using G*Power, with α = 0.05 and power = 80% according to repeated-measure analysis of variance (ANOVA) with two groups and three measurements. This study requires a sample size of 74 [66]. Based on this information and considering a study discontinuation rate of 17–18% [67], we plan to include a total of 86 patients (43 per group) in this study.

Data analysis plan

All patient data will be included in the analysis. IBM SPSS Statistics (version 20.0; IBM Corp., Armonk, NY, USA) will be used to perform statistical analysis. Descriptive statistics (e.g., mean, standard deviation, median, frequency, and percentage) will be used to present data. The homogeneity of basic attributes, disease treatment variables, and outcome variables in the experimental and attention control groups at the pretest stage will be assessed through independent sample t tests and chi-squared tests. The effect of the intervention will be determined using a generalized estimating equation. Two-tailed tests will be used, and P values ≤ 0.05 will denote statistically significant differences.


This study is the first to investigate the effects of the developed SMI-UI on the urinary symptoms and disturbance, cancer-related self-efficacy, social participation and satisfaction, resilience, and demoralization of patients with prostate cancer. An application can improve self-care among patients with prostate cancer [17]. In this study, through the use of the mobile self-management application, health education handbook, and professional support, this intervention will guide patients through learning strategies for managing urinary incontinence. Moreover, patients will develop skills for the prevention and management of urinary incontinence as well as for the avoidance or reduction of the impact of urinary incontinence on daily life, social activities, and leisure activities. Patients can also record the severity of urinary incontinence, usage of diapers, and frequency of PFME implementation through the application, which is expected to help them implement self-management activities [17]. The application can also represent the data input of patients in iconic form and can provide immediate feedback, thereby helping patients with prostate cancer to strengthen their self-management of urinary incontinence.

Most patients and their families dislike staying in the hospital for a long time, especially during the COVID-19 pandemic [68]. This motivated our research team to develop the mobile self-management application, to design research-related activities that can be completed and understood within a limited time, and to provide telecare. This has led to the practice of professionals providing support through telephone calls with the help of a mobile self-management application and handbook. To improve the efficacy of telephonic communication, the topics scheduled for discussion in each unit after the introduction of successful cases are prepared in multimedia format, and sufficient time is allotted for patients to think and provide their feedback in the handbook. Thereafter, the intervention provider is to conduct individual telephone discussions with the patients to provide effective support.

This study began in May 2022, but because of the COVID-19 pandemic, many hospital beds had to be reassigned to patients with COVID-19, and nonemergency surgery and medical treatment had to be postponed or delayed in accordance with the national and hospital pandemic prevention policies. Therefore, the number of patients who underwent surgical treatment was considerably lower than that recorded before the pandemic [68]. The inclusion period for this study definitely therefore needs to be extended to reach the desired sample size to provide sufficient statistical power.

Current study status

At the time of this submission, 68 of 90 participants have been recruited and randomized into two groups.

Fig. 1
figure 1

Intervention research framework

Fig. 2
figure 2

Steps used for the development of the self-management intervention

Fig. 3
figure 3

Self-management application

Fig. 4
figure 4

Flowchart of data collection

Fig. 5
figure 5

SPIRIT figure: Schedule of enrollment, interventions, and assessments. Note: ECOG = Eastern Cooperative Oncology Group, PSA = Prostate-specific antigen, SMI-UI = Self-management intervention for urinary incontinence, aexperimental group only

Table 1 Intervention strategies corresponding to key concepts of social cognitive theory
Table 2 Topics of self-management for urinary incontinence

Data Availability

No data was used for the research described in the article.


  1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49.

    Article  PubMed  Google Scholar 

  2. National Comprehensive Cancer Network (NCCN). Prostate Cancer Version 1. 2023; 2023. Available from:

  3. Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, et al. Quality of life and satisfaction with outcome among Prostate-cancer survivors. N Engl J Med. 2008;358(12):1250–61.

    Article  CAS  PubMed  Google Scholar 

  4. Eilat-Tsanani S, Tabenkin H, Shental J, Elmalah I, Steinmetz D. Patients’ perceptions of radical prostatectomy for localized Prostate cancer: a qualitative study. Isr Med Assoc J. 2013;15(3):153–7.

    PubMed  Google Scholar 

  5. Wennerberg C, Schildmeijer K, Hellström A, Ekstedt M. Patient experiences of self-care management after radical prostatectomy. Eur J Oncol Nurs. 2021;50:101894.

    Article  PubMed  Google Scholar 

  6. Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Tsay PK, Chang YH, Huang XY, Liu HE. Effects of individual and partner factors on anxiety and depression in Taiwanese Prostate cancer patients: a longitudinal study. Eur J Cancer Care (Engl). 2018;27(2):e12753.

    Article  CAS  PubMed  Google Scholar 

  7. Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Chang YH. Positive and negative affect and prostate cancer-specific anxiety in Taiwanese patients and their partners. Eur J Oncol Nurs. 2018;37:1–11.

    Article  PubMed  Google Scholar 

  8. Ignatius J, Garza IIRDL. Frequency of demoralization and depression in cancer patients. Gen Hosp Psychiatry. 2019;60:137–40.

    Article  CAS  PubMed  Google Scholar 

  9. Nanni MG, Caruso R, Travado L, Ventura C, Palma A, Berardi AM, Meggiolaro E, Ruffilli F, Martins C, Kissane D, et al. Relationship of demoralization with anxiety, depression, and quality of life: a southern European study of Italian and Portuguese cancer patients. Psychooncology. 2018;27(11):2616–22.

    Article  PubMed  Google Scholar 

  10. Chien CH, Chuang CK, Liu KL, Huang XY, Liu HE. Psychosocial adjustments in patients with Prostate cancer from pre-diagnosis to 6 months post-treatment. Int J Nurs Pract. 2016;22(1):70–8.

    Article  PubMed  Google Scholar 

  11. Corner J, Wagland R, Glaser A, Richards SM. Qualitative analysis of patients’ feedback from a PROMs survey of cancer patients in England. BMJ Open. 2013;3(4).

  12. Chien CH, Pang ST, Chuang CK, Liu KL, Wu CT, Yu KJ, Huang XY, Lin PH. Exploring psychological resilience and demoralisation in Prostate cancer survivors. Eur J Cancer Care (Engl). 2022;31(6):e13759.

    Article  PubMed  Google Scholar 

  13. Sharpley CF, Bitsika V, Christie DRH, Bradford R, Steigler A, Denham JW. Psychological resilience aspects that mediate the depressive effects of urinary incontinence in Prostate cancer survivors 10 years after treatment with radiation and hormone ablation. J Psychosoc Oncol. 2017;35(4):438–50.

    Article  PubMed  Google Scholar 

  14. Faithfull S, Cockle-Hearne J, Khoo V. Self-management after Prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms. BJU Int. 2011;107(5):783–90.

    Article  PubMed  Google Scholar 

  15. Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-management in long-term Prostate cancer survivors: a randomized, controlled trial. J Clin Oncol. 2019;37(15):1326–35.

  16. Martín-Núñez J, Heredia-Ciuró A, Valenza-Peña G, Granados-Santiago M, Hernández-Hernández S, Ortiz-Rubio A, Valenza MC. Systematic review of self-management programs for Prostate cancer patients, a quality of life and self-efficacy meta-analysis. Patient Educ Couns. 2023;107:107583.

    Article  PubMed  Google Scholar 

  17. Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklöf A. Engagement in an interactive app for symptom self-management during treatment in patients with breast or Prostate cancer: mixed methods study. J Med Internet Res. 2020;22(8):e17058.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1–7.

    Article  PubMed  Google Scholar 

  19. Xu A, Wang Y, Wu X. Effectiveness of e-health based self-management to improve cancer-related fatigue, self-efficacy and quality of life in cancer patients: systematic review and meta-analysis. J Adv Nurs. 2019;75(12):3434–47.

    Article  PubMed  Google Scholar 

  20. Lambert SD, Duncan LR, Culos-Reed SN, Hallward L, Higano CS, Loban E, Katz A, De Raad M, Ellis J, Korman MB, et al. Feasibility, acceptability, and clinical significance of a dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO) tailored to the needs of men with Prostate cancer and their caregivers: a multi-center randomized pilot trial. Curr Oncol. 2022;29(2):785–804.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Murphy KM, Sauer C, Yang D, Hass N, Novakovic K, Helfand B, Nadler R, Schalet BD, Victorson D. The development of iManage-PC, an online symptom monitoring and self-management tool for men with clinically localized Prostate cancer. Cancer Nurs. 2022;45(1):E309–e19.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Paterson C, Primeau C, Pullar I, Nabi G. Development of a prehabilitation multimodal supportive care interventions for men and their partners before radical prostatectomy for localized Prostate cancer. Cancer Nurs. 2019;42(4):E47–e53.

    Article  PubMed  Google Scholar 

  23. Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, Kresevic D, Moore S, Ponsky L, Purdum M, Strauss G, et al. Effects of patient centered interventions on persistent urinary incontinence after Prostate cancer treatment: a randomized, controlled trial. J Urol. 2015;194(6):1675–81.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Cockle-Hearne J, Barnett D, Hicks J, Simpson M, White I, Faithfull S. A web-based intervention to reduce distress after Prostate cancer treatment: development and feasibility of the getting down to coping program in two different clinical settings. JMIR Cancer. 2018;4(1):e8.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized Prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021;15(1):99–108.

    Article  PubMed  Google Scholar 

  26. Kazer MW, Bailey DE Jr., Sanda M, Colberg J, Kelly WK. An internet intervention for management of uncertainty during active surveillance for Prostate cancer. Oncol Nurs Forum. 2011;38(5):561–8.

    Article  PubMed  Google Scholar 

  27. Nilsson L, Hellström A, Wennerberg C, Ekstedt M, Schildmeijer K. Patients’ experiences of using an e-Health tool for self-management support after Prostate cancer Surgery: a deductive interview study explained through the FITT framework. BMJ Open. 2020;10(6):e035024.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Zhang X, Deng Z, Parvinzamir F, Dong F. MyHealthAvatar lifestyle management support for cancer patients. Ecancermedicalscience. 2018;12:849.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Obro LF, Osther PJS, Ammentorp J, Pihl GT, Heiselberg KK, Krogh PG, Handberg C. An intervention Offering Self-management support through mHealth and health coaching to patients with Prostate Cancer: interpretive description of patients’ experiences and perspectives. JMIR Form Res. 2022;6(9):e34471.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Bowler M, Dehek R, Thomas E, Ngo K, Grose L. Evaluating the impact of post-treatment self-management guidelines for Prostate cancer survivors. J Med Imaging Radiat Sci. 2019;50(3):398–407.

    Article  PubMed  Google Scholar 

  31. Frankland J, Brodie H, Cooke D, Foster C, Foster R, Gage H, Jordan J, Mesa-Eguiagaray I, Pickering R, Richardson A. Follow-up care after treatment for Prostate cancer: evaluation of a supported self-management and remote surveillance programme. BMC Cancer. 2019;19(1):368.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Paterson C, Roberts C, Toohey K, McKie A. Prostate cancer prehabilitation and the importance of multimodal interventions for person-centred care and recovery. Semin Oncol Nurs. 2020;36(4):151048.

    Article  CAS  PubMed  Google Scholar 

  33. Glanz K, Rimer BK, Viswanath K. Health Behavior: theory, Research, and practice. 5th ed. USA: Jossey-Bass; 2015.

    Google Scholar 

  34. Duijts SFA, Bleiker EMA, Paalman CH, van der Beek AJ. A behavioural approach in the development of work-related interventions for cancer survivors: an exploratory review. Eur J Cancer Care (Engl). 2017;26(5).

  35. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191–215.

    Article  CAS  PubMed  Google Scholar 

  36. Schwarzer R, Warner LM. Perceived self-efficacy and its relationship to resilience. In: Resilience in children, adolescents, and adults. edn. Edited by Prince-Embury S, Saklofske DH. New York: Springer; 2013;139 – 50.

  37. Bandura A. Self-efficacy: the exercise of control. New York: W.H. Freeman and Company; 1997.

    Google Scholar 

  38. Foster C, Breckons M, Cotterell P, Barbosa D, Calman L, Corner J, Fenlon D, Foster R, Grimmett C, Richardson A, et al. Cancer survivors’ self-efficacy to self-manage in the year following primary treatment. J Cancer Surviv. 2015;9(1):11–9.

    Article  CAS  PubMed  Google Scholar 

  39. Foster C, Fenlon D. Recovery and self-management support following primary cancer treatment. Br J Cancer. 2011;105(Suppl 1):21–8.

    Article  Google Scholar 

  40. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Aycock DM, Hayat MJ, Helvig A, Dunbar SB, Clark PC. Essential considerations in developing attention control groups in behavioral research. Res Nurs Health. 2018;41(3):320–8.

    Article  PubMed  Google Scholar 

  42. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–55.

    Article  CAS  PubMed  Google Scholar 

  43. Walters SJ, Henriques-Cadby BDA, Bortolami I, Flight O, Hind L, Jacques D, Knox RM, Nadin C, Rothwell B, Surtees J. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Liu KL, Chuang CK, Pang ST, Wu CT, Yu KJ, Tsai SC, Chien CH. Emotional state and cancer-related self-efficacy as affecting resilience and quality of life in kidney cancer patients: a cross-sectional study. Support Care Cancer. 2022;30(3):2263–71.

    Article  PubMed  Google Scholar 

  45. Foster C, Breckons M, Hankins M, Fenlon D, Cotterell P. Developing a scale to measure self-efficacy to SELF-manage problems following cancer treatment. Psychooncology. 2013;22(Supp 1):16.

    Google Scholar 

  46. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded Prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with Prostate cancer. Urology. 2000;56(6):899–905.

    Article  CAS  PubMed  Google Scholar 

  47. Chien CH, Chuang CK, Liu KL, Huang XY, Pang ST, Wu CT, Chang YH, Liu HE. Individual and mutual predictors of marital satisfaction among Prostate cancer patients and their spouses. J Clin Nurs. 2017;26(23–24):4994–5003.

    Article  PubMed  Google Scholar 

  48. Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-Davidson Resilience Scale (CD-RISC): validation of a 10-item measure of resilience. J Trauma Stress. 2007;20(6):1019–28.

    Article  PubMed  Google Scholar 

  49. Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76–82.

    Article  PubMed  Google Scholar 

  50. Meng M, He J, Guan Y, Zhao H, Yi J, Yao S, Li L. Factorial invariance of the 10-item Connor-Davidson Resilience Scale across gender among Chinese elders. Front Psychol. 2019;10:1237.

    Article  PubMed  PubMed Central  Google Scholar 

  51. Hung HC, Chen HW, Chang Y-F, Yang YC, Liu CL, Hsieh R-K, Leu YS, Chen YJ, Wang T-E, Tsai LY, et al. Evaluation of the reliability and validity of the Mandarin version of demoralization scale for cancer patients. J Intern Med Taiwan. 2010;21:427–35.

    Article  Google Scholar 

  52. Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The demoralization scale: a report of its development and preliminary validation. J Palliat Care. 2004;20(4):269–76.

    Article  PubMed  Google Scholar 

  53. Lee HM. The preliminary study on measure of elder’ meaning in life and related factors. J SHU-TE Univ. 2013;15(1):125–54.

    Google Scholar 

  54. Brubaker L. Patient education: Pelvic floor muscle exercises (Beyond the Basics); 2021. Available from: UpToDate.

  55. Clemens JQ. Urinary incontinence in men; 2022. Available from: UpToDate.

  56. Comiter CV, Speed J. Urinary incontinence after prostate treatment; 2021. Available from: UpToDate.

  57. Feng D, Liu S, Li D, Han P, Wei W. Analysis of conventional versus advanced pelvic floor muscle training in the management of urinary incontinence after radical prostatectomy: a systematic review and meta-analysis of randomized controlled trials. Transl Androl Urol. 2020;9(5):2031–45.

    Article  PubMed  PubMed Central  Google Scholar 

  58. Klein EA. Radical prostatectomy for localized prostate cancer; 2020. Available from: UpToDate.

  59. Lukacz ES. Treatment of urinary incontinence in females; 2021. Available from: UpToDate.

  60. McConnell KE, Corbin CB, Corbin DE, Farrar TD. Health for life. United States: Human Kinetics; 2014.

    Google Scholar 

  61. Strączyńska A, Weber-Rajek M, Strojek K, Piekorz Z, Styczyńska H, Goch A, Radzimińska A. The impact of pelvic floor muscle training on urinary incontinence in men after radical prostatectomy (RP) - a systematic review. Clin Interv Aging. 2019;14:1997–2005.

    Article  PubMed  PubMed Central  Google Scholar 

  62. Van de Zutter VD, Satink F, Costa T, Janquart U, Senn S, De Vriendt D. Delineating the concept of self-management in chronic conditions: a concept analysis. BMJ Open. 2019;9(7):e027775.

    Article  PubMed  PubMed Central  Google Scholar 

  63. Chien CH, Chung HJ, Liu KL, Pang ST, Wu CT, Chang YH, Huang XY, Chang YH, Lin TP, Lin WY, et al. Effectiveness of a couple-based psychosocial intervention on patients with Prostate cancer and their partners: a quasi-experimental study. J Adv Nurs. 2020;76(10):2572–85.

    Article  PubMed  Google Scholar 

  64. Cohen J. Satistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum; 1988.

    Google Scholar 

  65. Zhu J, Ebert L, Liu X, Wei D, Chan SW. Mobile Breast cancer e-support program for Chinese women with Breast cancer undergoing chemotherapy (part 2): Multicenter randomized controlled trial. JMIR Mhealth Uhealth. 2018;6(4):e104.

    Article  PubMed  PubMed Central  Google Scholar 

  66. Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149–60.

    Article  PubMed  Google Scholar 

  67. Crutzen R, Viechtbauer W, Spigt M, Kotz D. Differential attrition in health behaviour change trials: a systematic review and meta-analysis. Psychol Health. 2015;30(1):122–34.

    Article  PubMed  Google Scholar 

  68. Dhada S, Stewart D, Cheema E, Hadi MA, Paudyal V. Cancer services during the COVID-19 pandemic: systematic review of patient’s and caregiver’s experiences. Cancer Manag Res. 2021;13:5875–87.

    Article  PubMed  PubMed Central  Google Scholar 

Download references


We appreciate the National Science and Technology Council, Taipei City, Taiwan, R.O.C., for supporting this project.


This project was founded by the National Science and Technology Council, Taipei City, Taiwan, R.O.C. (Grant number: 110-2314-B-227 -005 -MY2).

Author information

Authors and Affiliations



CHC: Conceptualization, methodology, acquisition of funding, investigation, data curation, writing - original draft, writing - review & editing, visualization, supervision, project administration; LKK, PST, CKC: Conceptualization, investigation, resources, project administration, writing - review & editing; HXY: Conceptualization, project administration, writing - review & editing; WCT, YKJ, LPH: Investigation, resources, project administration, writing - review & editing. All authors reviewed the manuscript.

Corresponding authors

Correspondence to Ching Hui Chien or See Tong Pang.

Ethics declarations

Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki. Accordingly, approval was granted by the Chang Gung Medical Foundation Institutional Review Board (No. 201902235B0). Informed consent will be obtained from study participants.

Consent for publication

Not Applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and Permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Chien, C.H., Liu, K.L., Wu, C.T. et al. Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study. BMC Urol 23, 193 (2023).

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: