Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01785576
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2013-02-05
Brief Title:
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Status:
COMPLETED
Status Verified Date:
2019-07
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:
CoupleCare
Brief Summary:
The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer
Detailed Description:
This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills In addition in order to gather information on outcome variables couples will complete three assessments during the course of treatment pre-treatment following treatment and six month follow-up These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support We also will implement a daily diary assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed Patients and partners will participate in the daily diary portion of the study following the post-assessment They will be emailed an electronic link to a brief questionnaire daily for 7 days The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping spousal support and relationship satisfaction The patient will also complete questions about pain and fatigue
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