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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335967
• Other study ID #: 201902235B0C601
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Ching-Hui Chien, PhD
• Phone: +886-2-28227101
• Email: chinghui[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Self-Management

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital at Keelung	Keelung
Taiwan	Chang Gung Memorial Hospital at Linkou	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Chang Gung Memorial Hospital, National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

References & Publications (26)

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Jonkman NH, Schuurmans MJ, Groenwold RHH, Hoes AW, Trappenburg JCA. Identifying components of self-management interventions that improve health-related quality of life in chronically ill patients: Systematic review and meta-regression analysis. Patient Educ Couns. 2016 Jul;99(7):1087-1098. doi: 10.1016/j.pec.2016.01.022. Epub 2016 Feb 1. — View Citation

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Skolarus TA, Metreger T, Wittmann D, Hwang S, Kim HM, Grubb RL 3rd, Gingrich JR, Zhu H, Piette JD, Hawley ST. Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial. J Clin Oncol. 2019 May 20;37(15):1326-1335. doi: 10.1200/JCO.18.01770. Epub 2019 Mar 29. — View Citation

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Straczynska A, Weber-Rajek M, Strojek K, Piekorz Z, Styczynska H, Goch A, Radziminska A. The Impact Of Pelvic Floor Muscle Training On Urinary Incontinence In Men After Radical Prostatectomy (RP) - A Systematic Review. Clin Interv Aging. 2019 Nov 12;14:1997-2005. doi: 10.2147/CIA.S228222. eCollection 2019. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristic and disease information list 1	Age	Pre-test
Other	Demographic characteristic and disease information list 2	Marital status	Pre-test
Other	Demographic characteristic and disease information list 3	Education level	Pre-test
Other	Demographic characteristic and disease information list 4	Religious beliefs	Pre-test
Other	Demographic characteristic and disease information list 5	Employment status	Pre-test
Other	Demographic characteristic and disease information list 6	Cancer stage	Pre-test
Other	Demographic characteristic and disease information list 7	Chronic disease history	Pre-test
Other	Demographic characteristic and disease information list 8	Time of diagnosis (months)	Pre-test
Other	Demographic characteristic and disease information list 9	Treatment methods	Pre-test
Other	Demographic characteristic and disease information list 10	Latest serum level of prostate-specific antigen (ng/mL)	Pre-test
Other	Demographic characteristic and disease information list 11	Latest serum level of prostate-specific antigen (ng/mL)	12 weeks after the pretest
Other	Demographic characteristic and disease information list 12	Latest serum level of prostate-specific antigen (ng/mL)	16 weeks after the pretest
Other	Satisfaction and evaluation of self-management intervention	Self-designed five items will be used to assess these outcomes.Each item is scaled from 0 (worst) to 100 (best).	12 weeks after the pretest
Primary	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).	Pre-test
Primary	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).	12 weeks after the pretest
Primary	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).	16 weeks after the pretest
Primary	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.	Pre-test
Primary	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.	12 weeks after the pretest
Primary	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.	16 weeks after the pretest
Secondary	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.	Pre-test
Secondary	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.	12 weeks after the pretest
Secondary	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.	16 weeks after the pretest
Secondary	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.	Pre-test
Secondary	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.	12 weeks after the pretest
Secondary	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.	16 weeks after the pretest
Secondary	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.	Pre-test
Secondary	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.	12 weeks after the pretest
Secondary	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.	16 weeks after the pretest