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

July 11, 2025 updated by: Qian Sun, Sun Yat-sen University

The Effects of Dyadic Intervention for Young and Middle-aged Couples Facing Colorectal Cancer: A Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The Sixth Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
The control group to receive the usual care provided by the clinical team in the hospital.
Experimental: 6-week dyadic intervention
A 6-week psychosocial dyadic programme comprises 6 weekly 60-90min internet-based sessions.
Other: 6-week dyadic intervention
Comprising 6 weekly 60-90min internet-based sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Illness Cognition Questionnaire
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
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 (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Dyadic Coping Inventory
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
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.
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
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
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.
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
Time Frame: 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 was used to measure marriage quality. Total score was 0-158 points, although higher scores suggest better marriage quality.
Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Mutual communication
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Cancer- Related Communication Problems within Couple Scale (CRCP) is a 15- item measure assessing cancer- related communication problems within a cancer couple (e.g. 'My spouse does not ask how cancer affected my life' for patients, and 'My spouse does not ask about how him/her having cancer affects my life' for SCs; Kornblith et al., 2006). Higher scores demonstrate more communication problems within a cancer couple. Coefficient alpha in Chinese cancer patients and their SCs were .805 and .737, respectively (Li et al., 2015).
Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Caregiving burden
Time Frame: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
The Zarit Burden Inventory (Zarit Burden Inventory, ZBI) (Appendix 8) was used to assess the care burden of spouses of colorectal cancer patients. This scale was introduced by Wang Lie et al. [227] in 2006. It consists of 22 items and assesses the social life, economic status, mental status and health status of the primary caregivers in four aspects. The total score ranges from 0 to 88 points. The higher the score, the heavier the care burden. The Cronbach's α coefficient of this scale is 0.87
Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qian Sun, PhD student, Sun Yat-sen Univesity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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