Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Study Overview
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Brief Summary
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Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness. Methods: The investigators will develop a self-management program and conduct a pilot study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience.

Detailed Description
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Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness. Methods: The investigators will develop a self-management program and conduct a pilot study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. The self-management program is included a self-management application, a self-management manual, and professional support. The information package consists of a manual on a healthy diet and a multimedia film on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience. The statistical analyses will consist of independent sample t-tests, Chi-squire, and generalized estimating equation analysis.

Official Title
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Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Conditions
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Prostatic Neoplasms, Self-Management

Intervention / Treatment
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* Behavioral: Self-management program
* Other: Information package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer survivors will include if they fit the following: Received radical prostatectomy and suffering from urinary incontinence for at least one week Eastern Cooperative Oncology Group 0-1 point, able to walk entirely independently Have a smartphone or a tablet with a wireless network Their intimate partner or one of the family members willing to learn together Agreed to participate in the study and completed the informed consent form Exclusion Criteria: Prostate cancer survivors will be excluded if they had one or more of the following: A request, with the consideration of family members, that the medical team not tell the patient about the diagnosis or condition of the disease A history of psychiatric illness, such as dementia, depression; schizophrenia, or bipolar disorder Suffer from other types of cancer and actively undergoing treatment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management group<br>The experimental group will receive the self-management program for 12 weeks. | Behavioral: Self-management program<br>* The self-management group will receive the self-management program for 12 weeks, including a self-management application, a self-management manual, and Professional support.<br>|
| Other: Information group<br>The control group will receive an information package on a healthy diet. | Other: Information package<br>* The patients in this group will receive an information package on a healthy diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary symptoms and bothers | The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best). | Pre-test | 
| Urinary symptoms and bothers | The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best). | 12 weeks after the pretest | 
| Urinary symptoms and bothers | The Mandarin version of the Expanded Prostate Cancer Index Composite (EPIC) will be used to measure the urinary symptoms and bother of the participants. Total 7 items and each question is linearly scaled from 0 (worst) to 100 (best). | 16 weeks after the pretest | 
| Cancer related self-efficacy | The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy. | Pre-test | 
| Cancer related self-efficacy | The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy. | 12 weeks after the pretest | 
| Cancer related self-efficacy | The Mandarin version of the Cancer Survivors' Self-Efficacy Scale (CSSES) will be used to evaluate the cancer-specific self-efficacy of participants.The total score ranges from 11 to 110; the lower the score, the worse the self-efficacy. | 16 weeks after the pretest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social participation | The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation. | Pre-test | 
| Social participation | The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation. | 12 weeks after the pretest | 
| Social participation | The Mandarin version of the Older Adults Social Participation Scale will be used to assess participants' social participation. The scale includes 12 items with a score range of 12 to 60. A higher score shows a higher degree of social participation. | 16 weeks after the pretest | 
| Demoralization | The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization. | Pre-test | 
| Demoralization | The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization. | 12 weeks after the pretest | 
| Demoralization | The Mandarin version of the Demoralization Scale will be used to assess participants' demoralization. The scale includes 24 items, and the score range is 0-96. A higher score means higher demoralization. | 16 weeks after the pretest | 
| Resilience | The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience. | Pre-test | 
| Resilience | The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience. | 12 weeks after the pretest | 
| Resilience | The Mandarin version of the Connor-Davidson Resilience Scale will be used to measure the psychological resilience of participants. The scale has 10 items, and the score range is 0-100. A higher score reflects better resilience. | 16 weeks after the pretest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization