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

Sponsor

National Taipei University of Nursing and Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05335967

Collaborator

Chang Gung Memorial Hospital (Other)

Enrollment

Locations

Arms

15.3

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Self-Management	Behavioral: Self-management program Other: Information package	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 20, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Urinary symptoms and bothers [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).
Urinary symptoms and bothers [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).
Urinary symptoms and bothers [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).
Cancer related self-efficacy [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.
Cancer related self-efficacy [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.
Cancer related self-efficacy [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 Outcome Measures

Social participation [Pre-test]
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.
Social participation [12 weeks after the pretest]
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.
Social participation [16 weeks after the pretest]
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.
Demoralization [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.
Demoralization [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.
Demoralization [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.
Resilience [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.
Resilience [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.
Resilience [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.

Other Outcome Measures

Demographic characteristic and disease information list 1 [Pre-test]
Age
Demographic characteristic and disease information list 2 [Pre-test]
Marital status
Demographic characteristic and disease information list 3 [Pre-test]
Education level
Demographic characteristic and disease information list 4 [Pre-test]
Religious beliefs
Demographic characteristic and disease information list 5 [Pre-test]
Employment status
Demographic characteristic and disease information list 6 [Pre-test]
Cancer stage
Demographic characteristic and disease information list 7 [Pre-test]
Chronic disease history
Demographic characteristic and disease information list 8 [Pre-test]
Time of diagnosis (months)
Demographic characteristic and disease information list 9 [Pre-test]
Treatment methods
Demographic characteristic and disease information list 10 [Pre-test]
Latest serum level of prostate-specific antigen (ng/mL)
Demographic characteristic and disease information list 11 [12 weeks after the pretest]
Latest serum level of prostate-specific antigen (ng/mL)
Demographic characteristic and disease information list 12 [16 weeks after the pretest]
Latest serum level of prostate-specific antigen (ng/mL)
Satisfaction and evaluation of self-management intervention [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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