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

Not Applicable
Completed
Conditions
Self-Management
Prostatic Neoplasms
Interventions
Behavioral: Self-management program
Other: Information package
Registration Number
NCT05335967
Lead Sponsor
National Taipei University of Nursing and Health Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
85
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Self-management groupSelf-management programThe experimental group will receive the self-management program for 12 weeks.
Information groupInformation packageThe control group will receive an information package on a healthy diet.
Primary Outcome Measures
NameTimeMethod
Cancer related self-efficacy16 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 Outcome Measures
NameTimeMethod
Urinary symptoms and bothers16 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).

Social participation16 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.

Demoralization16 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.

Resilience16 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.

Trial Locations

Locations (2)

Chang Gung Memorial Hospital at Keelung

🇨🇳

Keelung, Taiwan

Chang Gung Memorial Hospital at Linkou

🇨🇳

Taoyuan, Taiwan

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