Clinical Trials Directory

Trials / Completed

CompletedNCT04590885

Coping Together: Couple-based Interventions for Cancer

Couple Communication Skills Training for Advanced Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
440 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCouple Communication Skills TrainingParticipants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
BEHAVIORALHealthy Lifestyle InformationParticipants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.

Timeline

Start date
2020-10-20
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2020-10-19
Last updated
2026-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04590885. Inclusion in this directory is not an endorsement.