Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04590885
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-10-09
Brief Title:
Coping Together Couple-based Interventions for Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Couple Communication Skills Training for Advanced Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCST2
Brief 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 spousesintimate partners Couples will be randomized 11 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 couples 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 eg 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 1To determine whether CCST significantly improves patients and partners individual psychological adjustment ie 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 eg 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
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 eg 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 1To determine whether CCST significantly improves patients and partners individual psychological adjustment ie 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None