Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors
NCT ID: NCT05335967
Last Updated: 2025-01-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
85 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-20
Study Completion Date
2024-07-31
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Prostatic Neoplasms
Self-Management
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Study Groups
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Self-management group
The experimental group will receive the self-management program for 12 weeks.
Group Type
EXPERIMENTAL
Self-management program
Intervention Type
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 group
The control group will receive an information package on a healthy diet.
Group Type
OTHER
Information package
Intervention Type
OTHER
The patients in this group will receive an information package on a healthy diet.
Interventions
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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.
Intervention Type
BEHAVIORAL
Information package
The patients in this group will receive an information package on a healthy diet.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
20 Years
Maximum Eligible Age
80 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Sponsor Role
collaborator
National Science and Technology Council
FED
Sponsor Role
collaborator
National Taipei University of Nursing and Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Ching-Hui Chien
RN, PhD, Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ching-Hui Chien, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
Locations
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Chang Gung Memorial Hospital at Keelung
Keelung, , Taiwan
Site Status
Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
Site Status
Countries
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Taiwan
References
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Chien CH, Liu KL, Wu CT, Chuang CK, Yu KJ, Lin PH, Huang XY, Pang ST. Development and assessment of a self-management intervention for urinary incontinence among patients with prostate cancer: protocol for a randomized feasibility study. BMC Urol. 2023 Nov 18;23(1):193. doi: 10.1186/s12894-023-01367-7.
Reference Type
BACKGROUND
Agochukwu NQ, Skolarus TA, Wittmann D. Telemedicine and prostate cancer survivorship: a narrative review. Mhealth. 2018 Oct 8;4:45. doi: 10.21037/mhealth.2018.09.08. eCollection 2018.
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BACKGROUND
An E, Lo C, Hales S, Zimmermann C, Rodin G. Demoralization and death anxiety in advanced cancer. Psychooncology. 2018 Nov;27(11):2566-2572. doi: 10.1002/pon.4843. Epub 2018 Aug 20.
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BACKGROUND
Baker H, Wellman S, Lavender V. Functional Quality-of-Life Outcomes Reported by Men Treated for Localized Prostate Cancer: A Systematic Literature Review. Oncol Nurs Forum. 2016 Mar;43(2):199-218. doi: 10.1188/16.ONF.199-218.
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BACKGROUND
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
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Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
Reference Type
BACKGROUND
Chien CH, Chuang CK, Liu KL, Huang XY, Liu HE. Psychosocial adjustments in patients with prostate cancer from pre-diagnosis to 6 months post-treatment. Int J Nurs Pract. 2016 Feb;22(1):70-8. doi: 10.1111/ijn.12360. Epub 2014 Oct 13.
Reference Type
BACKGROUND
Chien CH, Chung HJ, Liu KL, Pang ST, Wu CT, Chang YH, Huang XY, Chang YH, Lin TP, Lin WY, Chuang CK. Effectiveness of a couple-based psychosocial intervention on patients with prostate cancer and their partners: A quasi-experimental study. J Adv Nurs. 2020 Oct;76(10):2572-2585. doi: 10.1111/jan.14471. Epub 2020 Aug 3.
Reference Type
BACKGROUND
Chou MC, Chien CH, Chung HJ, Chuang CK, Wu CT, Pang ST, Liu KL, Chang YH. The Psychometric Properties of Taiwanese Version of the Memorial Anxiety Scale for Prostate Cancer. J Pain Symptom Manage. 2021 Apr;61(4):824-830. doi: 10.1016/j.jpainsymman.2020.10.013. Epub 2020 Oct 24.
Reference Type
BACKGROUND
Cockle-Hearne J, Faithfull S. Self-management for men surviving prostate cancer: a review of behavioural and psychosocial interventions to understand what strategies can work, for whom and in what circumstances. Psychooncology. 2010 Sep;19(9):909-22. doi: 10.1002/pon.1657.
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BACKGROUND
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Reference Type
BACKGROUND
Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklof A. Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study. J Med Internet Res. 2020 Aug 10;22(8):e17058. doi: 10.2196/17058.
Reference Type
BACKGROUND
Faithfull S, Cockle-Hearne J, Khoo V. Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms. BJU Int. 2011 Mar;107(5):783-790. doi: 10.1111/j.1464-410X.2010.09588.x. Epub 2010 Oct 13.
Reference Type
BACKGROUND
Foster C, Breckons M, Cotterell P, Barbosa D, Calman L, Corner J, Fenlon D, Foster R, Grimmett C, Richardson A, Smith PW. Cancer survivors' self-efficacy to self-manage in the year following primary treatment. J Cancer Surviv. 2015 Mar;9(1):11-9. doi: 10.1007/s11764-014-0384-0. Epub 2014 Jul 16.
Reference Type
BACKGROUND
Foster C, Fenlon D. Recovery and self-management support following primary cancer treatment. Br J Cancer. 2011 Nov 8;105 Suppl 1(Suppl 1):S21-8. doi: 10.1038/bjc.2011.419.
Reference Type
BACKGROUND
Frankland J, Brodie H, Cooke D, Foster C, Foster R, Gage H, Jordan J, Mesa-Eguiagaray I, Pickering R, Richardson A. Follow-up care after treatment for prostate cancer: evaluation of a supported self-management and remote surveillance programme. BMC Cancer. 2019 Apr 23;19(1):368. doi: 10.1186/s12885-019-5561-0.
Reference Type
BACKGROUND
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.
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BACKGROUND
Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The Demoralization Scale: a report of its development and preliminary validation. J Palliat Care. 2004 Winter;20(4):269-76.
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BACKGROUND
Xu A, Wang Y, Wu X. Effectiveness of e-health based self-management to improve cancer-related fatigue, self-efficacy and quality of life in cancer patients: Systematic review and meta-analysis. J Adv Nurs. 2019 Dec;75(12):3434-3447. doi: 10.1111/jan.14197. Epub 2019 Oct 20.
Reference Type
BACKGROUND
Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Song L, Guo P, Tan X, Chen RC, Nielsen ME, Birken SA, Koontz BF, Northouse LL, Mayer DK. Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. J Cancer Surviv. 2021 Feb;15(1):99-108. doi: 10.1007/s11764-020-00914-7. Epub 2020 Jul 17.
Reference Type
BACKGROUND
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.
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BACKGROUND
Sharpley CF, Bitsika V, Christie DRH, Bradford R, Steigler A, Denham JW. Psychological resilience aspects that mediate the depressive effects of urinary incontinence in prostate cancer survivors 10 years after treatment with radiation and hormone ablation. J Psychosoc Oncol. 2017 Jul-Aug;35(4):438-450. doi: 10.1080/07347332.2017.1306733. Epub 2017 Mar 20.
Reference Type
BACKGROUND
Roth AJ, Rosenfeld B, Kornblith AB, Gibson C, Scher HI, Curley-Smart T, Holland JC, Breitbart W. The memorial anxiety scale for prostate cancer: validation of a new scale to measure anxiety in men with with prostate cancer. Cancer. 2003 Jun 1;97(11):2910-8. doi: 10.1002/cncr.11386.
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Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
Reference Type
BACKGROUND
Other Identifiers
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201902235B0C601
Identifier Type: -
Identifier Source: org_study_id
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