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Completed

NCT Number: NCT05335967

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Self-management Urogenital Diseases Urogenital Neoplasms

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Management Program

Behavioral

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.

information package

Other

The patients in this group will receive an information package on a healthy diet.

Primary outcomes

  1. Cancer related self-efficacy

    Time frame: 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.

  2. Cancer related self-efficacy

    Time frame: 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.

  3. 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

  1. Urinary symptoms and bothers

    Time frame: 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).

  2. Urinary symptoms and bothers

    Time frame: 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).

  3. Urinary symptoms and bothers

    Time frame: 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).

  4. Social participation

    Time frame: Pre-test

    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.

  5. Social participation

    Time frame: 12 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.

  6. Social participation

    Time frame: 16 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.

  7. Demoralization

    Time frame: 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.

  8. Demoralization

    Time frame: 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.

  9. Demoralization

    Time frame: 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.

  10. Resilience

    Time frame: 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.

  11. Resilience

    Time frame: 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.

  12. Resilience

    Time frame: 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 outcomes

  1. Demographic characteristic and disease information list 1

    Time frame: Pre-test

    Age

  2. Demographic characteristic and disease information list 2

    Time frame: Pre-test

    Marital status

  3. Demographic characteristic and disease information list 3

    Time frame: Pre-test

    Education level

  4. Demographic characteristic and disease information list 4

    Time frame: Pre-test

    Religious beliefs

  5. Demographic characteristic and disease information list 5

    Time frame: Pre-test

    Employment status

  6. Demographic characteristic and disease information list 6

    Time frame: Pre-test

    Cancer stage

  7. Demographic characteristic and disease information list 7

    Time frame: Pre-test

    Chronic disease history

  8. Demographic characteristic and disease information list 8

    Time frame: Pre-test

    Time of diagnosis (months)

  9. Demographic characteristic and disease information list 9

    Time frame: Pre-test

    Treatment methods

  10. Demographic characteristic and disease information list 10

    Time frame: Pre-test

    Latest serum level of prostate-specific antigen (ng/mL)

  11. Demographic characteristic and disease information list 11

    Time frame: 12 weeks after the pretest

    Latest serum level of prostate-specific antigen (ng/mL)

  12. Demographic characteristic and disease information list 12

    Time frame: 16 weeks after the pretest

    Latest serum level of prostate-specific antigen (ng/mL)

  13. Satisfaction and evaluation of self-management intervention

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Chang Gung Memorial Hospital
  • National Science and Technology Council

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2022
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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