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

Primary Purpose

Prostatic Neoplasms, Self-Management

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-management program
Information package
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostatic Neoplasms focused on measuring Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Chang Gung Memorial Hospital at Keelung
  • Chang Gung Memorial Hospital at LinkouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Self-management group

Information group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Urinary symptoms and bothers
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
April 4, 2022
Last Updated
September 29, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Chang Gung Memorial Hospital, National Science and Technology Council
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1. Study Identification

Unique Protocol Identification Number
NCT05335967
Brief Title
Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors
Official Title
Development and Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Chang Gung Memorial Hospital, National Science and Technology Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Self-Management
Keywords
Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-management group
Arm Type
Experimental
Arm Description
The experimental group will receive the self-management program for 12 weeks.
Arm Title
Information group
Arm Type
Other
Arm Description
The control group will receive an information package on a healthy diet.
Intervention Type
Behavioral
Intervention Name(s)
Self-management program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information package
Intervention Description
The patients in this group will receive an information package on a healthy diet.
Primary Outcome Measure Information:
Title
Urinary symptoms and bothers
Description
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).
Time Frame
Pre-test
Title
Urinary symptoms and bothers
Description
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).
Time Frame
12 weeks after the pretest
Title
Urinary symptoms and bothers
Description
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).
Time Frame
16 weeks after the pretest
Title
Cancer related self-efficacy
Description
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.
Time Frame
Pre-test
Title
Cancer related self-efficacy
Description
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.
Time Frame
12 weeks after the pretest
Title
Cancer related self-efficacy
Description
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.
Time Frame
16 weeks after the pretest
Secondary Outcome Measure Information:
Title
Social participation
Description
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.
Time Frame
Pre-test
Title
Social participation
Description
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.
Time Frame
12 weeks after the pretest
Title
Social participation
Description
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.
Time Frame
16 weeks after the pretest
Title
Demoralization
Description
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.
Time Frame
Pre-test
Title
Demoralization
Description
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.
Time Frame
12 weeks after the pretest
Title
Demoralization
Description
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.
Time Frame
16 weeks after the pretest
Title
Resilience
Description
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.
Time Frame
Pre-test
Title
Resilience
Description
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.
Time Frame
12 weeks after the pretest
Title
Resilience
Description
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.
Time Frame
16 weeks after the pretest
Other Pre-specified Outcome Measures:
Title
Demographic characteristic and disease information list 1
Description
Age
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 2
Description
Marital status
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 3
Description
Education level
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 4
Description
Religious beliefs
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 5
Description
Employment status
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 6
Description
Cancer stage
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 7
Description
Chronic disease history
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 8
Description
Time of diagnosis (months)
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 9
Description
Treatment methods
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 10
Description
Latest serum level of prostate-specific antigen (ng/mL)
Time Frame
Pre-test
Title
Demographic characteristic and disease information list 11
Description
Latest serum level of prostate-specific antigen (ng/mL)
Time Frame
12 weeks after the pretest
Title
Demographic characteristic and disease information list 12
Description
Latest serum level of prostate-specific antigen (ng/mL)
Time Frame
16 weeks after the pretest
Title
Satisfaction and evaluation of self-management intervention
Description
Self-designed five items will be used to assess these outcomes.Each item is scaled from 0 (worst) to 100 (best).
Time Frame
12 weeks after the pretest

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hui Chien, PhD
Phone
+886-2-28227101
Ext
3103
Email
chinghui@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hui Chien, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Keelung
City
Keelung
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan-Lin Liu, MB
Email
Kuanlin@cgmh.org.tw
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan-Lin Liu, MB
Email
Kuanlin@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Kuan-Lin Liu, MB

12. IPD Sharing Statement

Plan to Share IPD
No
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Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

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