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

January 2, 2025 updated by: Ching-Hui Chien, National Taipei University of Nursing and Health Sciences

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

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Keelung, Taiwan
        • Chang Gung Memorial Hospital at Keelung
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital at Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-management group
The experimental group will receive the self-management program for 12 weeks.
Behavioral: Self-management program
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.
Other: Information group
The control group will receive an information package on a healthy diet.
Other: Information package
The patients in this group will receive an information package on a healthy diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer related self-efficacy
Time Frame: Pre-test
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
Time Frame: 12 weeks after the pretest
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
Time Frame: 16 weeks after the pretest
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
Urinary symptoms and bothers
Time Frame: Pre-test
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
Time Frame: 12 weeks after the pretest
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
Time Frame: 16 weeks after the pretest
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
Demoralization
Time Frame: Pre-test
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
Time Frame: 12 weeks after the pretest
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
Time Frame: 16 weeks after the pretest
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
Time Frame: Pre-test
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
Time Frame: 12 weeks after the pretest
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
Time Frame: 16 weeks after the pretest
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
Social participation
Time Frame: Pre-test

A. 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.

B. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
Pre-test
Social participation
Time Frame: 12 weeks after the pretest

A. 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.

B. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
12 weeks after the pretest
Social participation
Time Frame: 16 weeks after the pretest

A. 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.

B. Self-designed items will be used to assess participants' willingness to participate in social activities (1 item) and their satisfaction with social activities (1 item). Each item will have a score range of 0 to 10, with higher scores indicating a greater willingness to participate or higher satisfaction.
16 weeks after the pretest

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristic and disease information list 1
Time Frame: Pre-test
Age
Pre-test
Demographic characteristic and disease information list 2
Time Frame: Pre-test
Marital status
Pre-test
Demographic characteristic and disease information list 3
Time Frame: Pre-test
Education level
Pre-test
Demographic characteristic and disease information list 4
Time Frame: Pre-test
Religious beliefs
Pre-test
Demographic characteristic and disease information list 5
Time Frame: Pre-test
Employment status
Pre-test
Demographic characteristic and disease information list 6
Time Frame: Pre-test
Cancer stage
Pre-test
Demographic characteristic and disease information list 7
Time Frame: Pre-test
Chronic disease history
Pre-test
Demographic characteristic and disease information list 8
Time Frame: Pre-test
Time of diagnosis (months)
Pre-test
Demographic characteristic and disease information list 9
Time Frame: Pre-test
Treatment methods
Pre-test
Demographic characteristic and disease information list 10
Time Frame: Pre-test
Latest serum level of prostate-specific antigen (ng/mL)
Pre-test
Demographic characteristic and disease information list 11
Time Frame: 12 weeks after the pretest
Latest serum level of prostate-specific antigen (ng/mL)
12 weeks after the pretest
Demographic characteristic and disease information list 12
Time Frame: 16 weeks after the pretest
Latest serum level of prostate-specific antigen (ng/mL)
16 weeks after the pretest
Satisfaction and evaluation of self-management intervention
Time Frame: 12 weeks after the pretest
Self-designed five items will be used to assess these outcomes.Each item is scaled from 0 (worst) to 100 (best).
12 weeks after the pretest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Chang Gung Memorial Hospital
National Science and Technology Council

Investigators

  • Principal Investigator: Ching-Hui Chien, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201902235B0C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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