Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorNational Taipei University of Nursing and Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dyadic Co-learning Intervention

    Other 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Dyadic Co-learning Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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)
2

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)
3

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)
4

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)

Sponsors and contacts

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