Colorectal CancerNCT06326437
Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses
A study testing 6-week dyadic intervention in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 6-week dyadic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- 6-week dyadic intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-week dyadic interventionOther
Comprising 6 weekly 60-90min internet-based sessions.
| Study group | Role | What they receive |
|---|---|---|
| 6-week dyadic intervention | Experimental | A 6-week psychosocial dyadic programme comprises 6 weekly 60-90min internet-based sessions. Receives: Other: 6-week dyadic intervention |
| Usual care | No intervention | The control group to receive the usual care provided by the clinical team in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Secondary outcomes (6)
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.
Measured: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
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 α coefficient for the scale is 0.92, with individual dimension coefficients ranging from 0.67 to 0.91.
Measured: 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
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.
Measured: 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
Locke-Wallace Marital Adjustment Scale was used to measure marriage quality. Total score was 0-158 points, although higher scores suggest better marriage quality.
Measured: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Mutual communication
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).
Measured: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Caregiving burden
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
Measured: Changes from baseline (T0) to immediately (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 May 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Sun, Sun Yat-sen University
- Investigators
- Qian Sun, PhD student, Principal investigator, Sun Yat-sen Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326437
- Sponsor's protocol ID
- 1223
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dyadic Intervention for Young and Middle-aged Couples Facing Colorectal Cancer: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06326437
- Acronym / sponsor ID
- 1223
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-week dyadic intervention | Experimental | Other: 6-week dyadic interventionA 6-week psychosocial dyadic programme comprises 6 weekly 60-90min internet-based sessions. |
| Usual care | No intervention | –The control group to receive the usual care provided by the clinical team in the hospital. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-week dyadic interventionComprising 6 weekly 60-90min internet-based sessions. | Other | 6-week dyadic intervention |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
Mutual communication
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Sun, PhD student principal investigator
Sun Yat-sen Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-week dyadic intervention in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.