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Clinical Trials/NCT05335967
NCT05335967
Completed
Not Applicable

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

National Taipei University of Nursing and Health Sciences2 sites in 1 country85 target enrollmentMay 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
85
Locations
2
Primary Endpoint
Cancer related self-efficacy
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2022
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ching-Hui Chien

RN, PhD, Professor

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Urinary symptoms and bothers(16 weeks after the pretest)
  • Social participation(16 weeks after the pretest)
  • Demoralization(16 weeks after the pretest)
  • Resilience(16 weeks after the pretest)

Study Sites (2)

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