Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses

Colorectal Cancer Clinical Trial

Official title:

The Effect of Dyadic Intervention on Psychological Distress of Young and Middle-aged Patients With Colorectal Cancer and Their Spouses: a Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326437
• Other study ID #: 1223
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Qian Sun, PhD student
• Phone: +86 15616167998
• Email: sunq68[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• 6-week dyadic intervention
Comprising 1 session with 60-90min, followed by 5 weekly internet-based sessions.

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Kessler psychological distress scale-10	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.	Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Secondary	The Illness Cognition Questionnaire	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.	Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Secondary	Dyadic Coping Inventory	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 a coefficient for the scale is 0.92, with individual dimension coefficients ranging from 0.67 to 0.91.	Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Secondary	European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30	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 a coefficient for the overall quality of life scale is 0.809.	Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)
Secondary	Locke-Wallace Marital Adjustment Scale	Locke-Wallace Marital Adjustment Scale was used to measure marriage quality. Total score was 0-158 points, although higher scores suggest better marriage quality.	Changes from Baseline at the 1 months (after the intervention) and 3 months (follow-up)