An interventional study of Couple Communication Skills Training and Healthy Lifestyle Information in Advanced Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). We will evaluate CCST effects on a range of patient and partner relationship and psychological outcomes.
For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and the couple's collective well-being. Couples' ability to communicate openly and effectively with each other about cancer-related concerns can improve their psychological adjustment and quality of their relationship. Open and effective communication may also lead to better symptom management and goal-concordant care. However, many couples report difficulties communicating about cancer, even in the context of overall satisfying relationships. This can have a number of deleterious consequences, including deficits in emotional support, decreases in intimacy and relationship quality, and increased psychological distress. Thus, interventions designed to facilitate effective communication between cancer patients and their partners are likely to have beneficial effects on both individual and relationship functioning.
Prior research, including studies conducted by our team, has found that couple-based interventions that target communication lead to positive outcomes for cancer patients and their partners. However, most prior studies have been limited by reliance on an in-person treatment delivery format which keeps many couples from participating. In addition, prior studies have not targeted interventions to couples who are most likely to benefit. There is increasing evidence that psychosocial interventions for cancer, including couple-based interventions, should be targeted to those at risk of poor outcomes. Our prior research indicates that couples who report communication difficulties (e.g., high levels of holding back from discussing cancer-related concerns) have increased psychological distress and poorer relationship functioning and are most likely to benefit from a couple communication intervention specifically designed to addressed their communication problems.
The specific aims of this study are (1)To determine whether CCST significantly improves patients' and partners' individual psychological adjustment (i.e., psychological distress, life completion) and patient health and health care outcomes (physical well-being, symptom distress, advance care planning discussions and completion of advance directives, hospitalizations, and emergency department visits) compared to an education condition. (2) To determine whether, for couples receiving the CCST intervention, improvements in psychological adjustment, relationship functioning, and patient health are mediated by improvements in their communication, including objective measures of communication quality and communal coping (e.g., "we-talk") derived from couple conversations and self-reported protective buffering. (3) To examine differences in response to the CCST intervention for patients versus partners, for male versus female participants, and for patients with different cancer diagnoses (breast, lung, GI, GU). (4) To conduct an implementation-related process evaluation of the intervention.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
CCST includes components to assist couples in communicating effectively, decreasing avoidance of important cancer-related issues, and providing each other with support. It includes training in skills for sharing one's thoughts and feelings and listening to one's partner and responding in a supportive manner, and joint problem solving. Participants will be asked to participate inactivities at home between sessions to strengthen skills acquisition.
Behavioral: Couple Communication Skills Training
Healthy Lifestyle Information provides couples with health information relevant to cancer in a supportive environment. Sessions focus on the following topics: fatigue, sleep disturbance, nutrition, physical activity, survivorship care plans, and palliative care. Patients and partners are invited to discuss their experiences around the session topics with the therapist and ask questions about the information presented.
Behavioral: Healthy Lifestyle Information
Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
Also known as: CCST
Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.
Also known as: HLI
Changes in patient relationship functioning
Change in patient relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner relationship functioning
Change in partner relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient relationship functioning
Change in patient intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner relationship functioning
Change in partner intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient life completion measured by the Life Completion scale of the QUAL-E (higher scores indicate higher completion)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner life completion measured by the Life Completion scale of the QUAL-E Family (higher scores indicate higher completion)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient physical well being as measured by the Physical Well Being subscale of the Functional Assessment of Cancer Therapy scale (higher scores indicate higher physical well being)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient and partner psychological functioning
Change in symptom distress as measured by the Condensed Memorial Symptom Assessment Scale (higher scores indicate higher symptom distress)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient advance care planning discussions (presence or absence, via patient self-report)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient completion of advanced directives (presence or absence, via patient self-report)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient hospitalizations (number of hospitalizations per patient self-report, validated by medical record review)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient emergency department visits (number of emergency department visits per patient self-report, validated by medical record review)
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
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