Colorectal Cancer
Conditions
Brief 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. 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.
Interventions
OTHER6-week dyadic intervention
Comprising 6 weekly 60-90min internet-based sessions.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Kessler psychological distress scale-10 | 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
| Measure | Time frame | Description |
|---|---|---|
| Dyadic Coping Inventory | 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. |
| European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 | 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. |
| The Illness Cognition Questionnaire | 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. |
| Mutual communication | 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). |
| Caregiving burden | 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 |
| Locke-Wallace Marital Adjustment Scale | 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. |
Countries
China
Outcome results
None listed