Prostatic Neoplasms, Self-Management
Conditions
Keywords
Prostate cancer, Self-Management, Social participation, Resilience, Rear of cancer recurrence, Self-efficacy, Demoralization
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 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 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.
Interventions
BEHAVIORALSelf-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.
OTHERInformation package
The patients in this group will receive an information package on a healthy diet.
Sponsors
Chang Gung Memorial Hospital
National Science and Technology Council
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Social participation | 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 9 | Pre-test | Treatment methods |
| Demographic characteristic and disease information list 6 | Pre-test | Cancer stage |
| Demographic characteristic and disease information list 7 | Pre-test | Chronic disease history |
| 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). |
| Demographic characteristic and disease information list 5 | Pre-test | Employment status |
| 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) |
| Demographic characteristic and disease information list 8 | Pre-test | Time of diagnosis (months) |
Countries
Taiwan
Outcome results
None listed