Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Registration Number
- NCT07196488
- Brief Summary
This study aims to help patients with prostate cancer and their spouses cope better with the challenges of cancer by learning and supporting each other together. The investigators will test an 8-week "Dyadic Co-learning Intervention," which includes weekly learning topics, a mobile app, and professional support. The goal is to improve their physical symptoms, emotional well-being, and resilience.
Participants will be randomly assigned to one of two groups. One group will receive regular care, while the other group will receive regular care plus the new co-learning program. The investigators will ask both patients and their spouses to complete questionnaires at the beginning of the study, and again at 10 and 16 weeks, to understand how the program affects their health and well-being.
- Detailed Description
Objective:
To evaluate the effectiveness of a Dyadic Co-learning Intervention for patients with prostate cancer and their spouses, focusing on physical symptoms, emotional well-being, and resilience.
Study Design:
An experimental, two-group, randomized controlled design will be adopted. Participants will be recruited through convenience sampling from the urology outpatient department and inpatient wards of a hospital. Patients diagnosed with prostate cancer and their cohabiting spouses who agree to participate will provide written informed consent prior to data collection.
Procedures:
Baseline data (Time 0) will be collected using structured questionnaires. After completing the pretest assessment, patient-spouse dyads will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.
The intervention group will receive routine care plus an 8-week Dyadic Co-learning Intervention, while the control group will receive routine care only.
Follow-up assessments will be conducted at the 10th week (Time 1) and the 16th week (Time 2) after the baseline to evaluate intervention outcomes.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
For Patients:
- Diagnosed with prostate cancer by a board-certified urologist.
- Has either decided on a treatment plan or completed treatment within the past two years.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
For Spouses:
- Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.
- Must have a Barthel Index score of 91 or above, indicating good functional independence.
Either the patient or the spouse will be excluded if:
- Diagnosed with another type of cancer.
- Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Family Resilience (patients and spouses) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test This study will adopt the Chinese version of the Walsh Family Resilience Questionnaire to assess family resilience in patients with prostate cancer and their spouses. The scale uses a 5-point Likert rating, ranging from 1 (Never) to 5 (Always). Total scores range from 26 to 130, with higher scores indicating greater levels of family resilience.
- Secondary Outcome Measures
Name Time Method Physical Symptoms and Distress (patients only) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test This study will use the Chinese version of the Expanded Prostate Cancer Index Composite (EPIC-26) to assess symptoms and related distress in patients with prostate cancer. The scale consists of 26 items covering four domains: urinary incontinence, urinary irritation/obstruction, bowel symptoms and distress, sexual function and distress, and vitality/hormonal function and distress. Total scores range from 0 to 100, which higher scores indicate fewer symptoms and less distress.
Resilience (patients and spouses) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test he 10-item version of the Connor-Davidson Resilience Scale (CD-RISC-10) will be used to measure individual resilience among both prostate cancer patients and their spouses. Each item is scored on a scale from 0 to 4, with total scores ranging from 0 to 40. Higher scores indicate greater resilience.
Fatigue (patients only) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test The Taiwanese version of the Brief Fatigue Inventory (BFI) will be used to assess the severity of cancer-related fatigue over the past 24 hours and its impact on daily life in patients with prostate cancer. The instrument consists of 9 items; each rated on an 11-point scale ranging from 0 to 10. Higher scores indicate greater fatigue severity or greater interference with daily activities.
Subjective Well-Being (patients and spouses) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test The Chinese Subjective Well-Being Scale, developed specifically for Chinese populations, will be used to measure subjective well-being among patients and their spouses. The scale includes 10 items rated on a 4-point scale (0-3), with total scores ranging from 0 to 30. Higher scores indicate greater perceived well-being.
Loneliness (patients and spouses) Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test The Chinese version of the Loneliness Scale will be used to assess the level of loneliness in both prostate cancer patients and their spouses. The scale consists of 9 items, covering two subscales: social loneliness and emotional loneliness. Each item is scored dichotomously (0 or 1), with total scores ranging from 0 to 9. Higher scores indicate a greater sense of loneliness.
Intervention Satisfaction (patients and spouses in intervention group) 10th weeks after the pre-test This questionnaire consists of five items designed to assess participants' satisfaction with the intervention program, including the mobile application, multimedia videos, handbook, and professional support. Each item will be scored on a scale from 0 to 100, with higher scores indicating greater satisfaction.