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Completed

NCT Number: NCT06326437

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

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.

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Key information

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6-week dyadic intervention

Other

Comprising 6 weekly 60-90min internet-based sessions.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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