About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.
Disqualifiers
Diagnosed with another type of cancer.
Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.
Trial design
Parallel
Treatments tested in this trial
Dyadic Co-learning Intervention
Other interventionParticipants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention, which will consist of three components: (1) a co-learning handbook, (2) a co-learning mobile app, and (3) professional support.
Treatment groups
Trial outcomes
Primary outcomes
Family Resilience (patients and spouses)
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 outcomes
Physical Symptoms and Distress (patients only)
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.
Fatigue (patients only)
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.
Resilience (patients and spouses)
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.
Loneliness (patients and spouses)
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.
Other outcomes
Age (Patients and Spouses)
The demographic information form will be used to collect the ages of patients and their spouses; a higher value indicates older age.
Education level (Patients and Spouses)
The demographic information form will be used to collect the education levels of patients and their spouses, categorized as: elementary school, junior high school, senior high school, college/university, and graduate degree.
Religious belief (Patients and Spouses)
The demographic information form will be used to collect the religious belief of patients and their spouses, categorized as: None, Buddhism, Taoism, Christianity, Catholicism, folk religion, and others.
Employment status (Patients and Spouses)
The demographic information form will be used to collect the employment status of patients and their spouses, categorized as: full-time employed, part-time employed, on medical leave (retaining employment), retired, unemployed, or other.
Sponsors and contacts
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National Taipei University of Nursing and Health Sciences
Lead sponsor
Chang Gung Memorial Hospital
Collaborator