The Effects of Dyadic Intervention for Young and Middle-aged Couples Facing Colorectal Cancer: A Randomised Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- the Kessler psychological distress scale-10
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The overall aim of the study is to evaluate the effects of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), illness-related communication, psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples were randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.
Investigators
Qian Sun
PhD student
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •patients and spouses aged 20 years or older patients diagnosed with colorectal cancer within the past year Patients scored ≥ 22 points on the Kessler Psychological Distress Scale assessment patients and spouses able to read simplified Chinese
Exclusion Criteria
- •psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
Outcomes
Primary Outcomes
the Kessler psychological distress scale-10
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
The scale employs a Likert 5-point rating system, ranging from "almost never" to "all the time" with values assigned from 1 to 5 respectively, yielding a total score between 10 and 50. Higher scores indicate greater levels of psychological distress, with a cutoff set at ≥22 points.
Secondary Outcomes
- The Illness Cognition Questionnaire(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)
- Dyadic Coping Inventory(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)
- Locke-Wallace Marital Adjustment Scale(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)
- Mutual communication(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)
- Caregiving burden(Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention)