Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses
- Conditions
- Colorectal Cancer
- Interventions
- Other: 6-week dyadic intervention
- Registration Number
- NCT06326437
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
patients and spouses aged 18 years or older patients diagnosed with colorectal cancer Patients scored ≥ 22 points on the Kessler Psychological Distress Scale assessment patients and spouses able to read simplified Chinese
psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6-week dyadic intervention 6-week dyadic intervention A 6-week psychosocial dyadic programme will comprise 1 weekly 60-90min face-to-face session, followed by 5 weekly internet-based sessions.
- Primary Outcome Measures
Name Time Method the Kessler psychological distress scale-10 Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up) 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 Outcome Measures
Name Time Method The Illness Cognition Questionnaire Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up) The Chinese version of the Illness Cognition Questionnaire comprises three dimensions: helplessness, acceptance, and perceived benefits, each featuring six items, totaling 18 items. It employs a Likert 4-point rating scale, ranging from "completely disagree" to "completely agree." Each dimension is scored independently, with scores ranging from 6 to 24. Higher scores indicate a heightened perception within the respective dimension, and scores from different dimensions are not aggregated.
Dyadic Coping Inventory Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up) The scale is designed to evaluate partners' joint coping behaviors in response to shared sources of stress. It utilizes a Likert 5-point rating system, where 1 represents "rarely" and 5 represents "very frequently." Notably, items 7, 10, 11, 15, 22, 25, 26, and 27 are reverse-scored. Additionally, items 36 and 37 assess self-rated satisfaction with binary strategy use and are excluded from the total score calculation. The overall Cronbach's α coefficient for the scale is 0.92, with individual dimension coefficients ranging from 0.67 to 0.91.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up) The scale, developed by the European Organization for Research and Treatment of Cancer, consists of 30 items. It evaluates five functional domains (physical, emotional, cognitive, social, and role functioning), nine symptom domains (nausea and vomiting, diarrhea, constipation, fatigue, pain, insomnia, appetite loss, dyspnea, and financial difficulties), and one overall health status domain. Scores range from 0 to 100, with higher scores indicating better quality of life. The Cronbach's α coefficient for the overall quality of life scale is 0.809.
Locke-Wallace Marital Adjustment Scale Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up) Locke-Wallace Marital Adjustment Scale was used to measure marriage quality. Total score was 0-158 points, although higher scores suggest better marriage quality.
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China