An interventional study of Dyadic Co-learning Intervention in Prostate Cancer (Adenocarcinoma), sponsored by National Taipei University of Nursing and Health Sciences. Recruiting at 2 sites in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Health services research
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Taipei University of Nursing and Health Sciences is the lead sponsor of 124 studies on the registry; 23 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Patients:
For Spouses:
Exclusion Criteria:
Either the patient or the spouse will be excluded if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group will receive routine care.
Participants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention.
Other: Dyadic Co-learning Intervention
Participants 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.
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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Subjective Well-Being (patients and spouses)
The Chinese Happiness Inventory, 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.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Intervention Satisfaction (patients and spouses in intervention group)
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.
Time frame: 10th weeks after the pre-test
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.
Time frame: Before the intervention (pre-test)
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.
Time frame: Before the intervention (pre-test)
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.
Time frame: Before the intervention (pre-test)
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.
Time frame: Before the intervention (pre-test)
Number of children (Patients and Spouses)
The demographic information form will be used to collect the ages of patients and their spouses; categorized as none, or number of sons and daughters (self-reported).
Time frame: Before the intervention (pre-test)
Relationship status (Patients and Spouses)
The demographic information form will be used to collect the relationship status of patients and their spouses, categorized as married, single/never married, divorced, widowed, cohabiting, or remarried.
Time frame: Before the intervention (pre-test)
Living arrangement (Patients)
The demographic information form will be used to collect the living arrangement of patients, categorized as living alone, living with spouse, living with spouse and children, living with spouse and grandchildren, living with grandchildren, or other.
Time frame: Before the intervention (pre-test)
Cancer stage (Patients)
The disease-related information form will be used to collect the cancer stage of patients.
Time frame: Before the intervention (pre-test)
Time since diagnosis (Patients)
The disease-related information form will be used to collect the time since diagnosis (in months) of patients.
Time frame: Before the intervention (pre-test)
Most recent PSA level (ng/mL) (Patients)
The disease-related information form will be used to collect the most recent PSA level (ng/mL) of patients.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Initial PSA level (ng/mL) (Patients)
The disease-related information form will be used to collect the initial PSA level (ng/mL) of patients.
Time frame: Before the intervention (pre-test)
Gleason score (Patients)
The disease-related information form will be used to collect the gleason score of patients.
Time frame: Before the intervention (pre-test)
Primary treatment method (Patients)
Primary treatment method for prostate cancer will be collected using the disease-related information form.
Time frame: Before the intervention (pre-test)
History of cancer recurrence (Patients)
The disease-related information form will be used to collect the history of cancer recurrence among patients.
Time frame: Before the intervention (pre-test)
Chronic disease history (Patients and Spouses)
Presence of comorbidities, assessed using the disease-related information form; categorized as none, or specified conditions (diabetes mellitus, asthma, gastrointestinal ulcer, glaucoma, hypertension, bronchitis, gastroesophageal reflux disease, cataract, heart disease, stroke, arthritis/degenerative joint disease, or other).
Time frame: Before the intervention (pre-test)
Perceived physical health status (Patients and Spouses)
The disease-related information form will be used to collect the perceived physical health status of patients and their spouses, with higher scores indicating better perceived physical health.
Time frame: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test
Menopausal status (Spouses)
Menopausal status (irregular menstruation but not complete cessation), assessed using the disease-related information form; categorized as yes/no.
Time frame: Before the intervention (pre-test)
History of menopause (Spouses)
History of menopause, assessed using the disease-related information form; categorized as yes/no. For participants who responded "yes," the age at menopause (in years) will be recorded.
Time frame: Before the intervention (pre-test)
Plan to share: No — Data supporting this study's findings are available from the corresponding author upon reasonable request. The data are not publicly available due to the consideration of ethics, the researchers shall maintain the privacy of the participants, and research data should be used only for academic articles.
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