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

National Taipei University of Nursing and Health Sciences

Status: Completed

Conditions: Prostatic Neoplasms; Self-Management

Treatments: Behavioral: Self-management program; Other: Information package

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05335967

201902235B0C601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

85 participants in 2 patient groups

Self-management group

Experimental group

Description:

The experimental group will receive the self-management program for 12 weeks.

Treatment:

Behavioral: Self-management program

Information group

Other group

Description:

The control group will receive an information package on a healthy diet.

Treatment:

Other: Information package