Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners (CoupleCare)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Couple-Based CBT Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring couples, head and neck cancer, oncology, spousal support
Eligibility Criteria
Inclusion Criteria:
- Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy
- No history of cancer within past 3 years (other than basal cell)
- Living with partner in a committed relationship at least 6 months
- Patient and partner speak and read English
Exclusion Criteria:
- Serious cognitive or emotional issues that preclude full participation in study
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Couple-Based CBT Intervention
Treatment as Usual
Arm Description
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Spousal Support
Full Information
NCT ID
NCT01785576
First Posted
February 5, 2013
Last Updated
July 19, 2019
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT01785576
Brief Title
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Acronym
CoupleCare
Official Title
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
couples, head and neck cancer, oncology, spousal support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Couple-Based CBT Intervention
Arm Type
Experimental
Arm Description
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.
Intervention Type
Behavioral
Intervention Name(s)
Couple-Based CBT Intervention
Intervention Description
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Spousal Support
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy
No history of cancer within past 3 years (other than basal cell)
Living with partner in a committed relationship at least 6 months
Patient and partner speak and read English
Exclusion Criteria:
Serious cognitive or emotional issues that preclude full participation in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Gremore, PhD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33106976
Citation
Gremore TM, Brockstein B, Porter LS, Brenner S, Benfield T, Baucom DH, Sher TG, Atkins D. Couple-based communication intervention for head and neck cancer: a randomized pilot trial. Support Care Cancer. 2021 Jun;29(6):3267-3275. doi: 10.1007/s00520-020-05848-5. Epub 2020 Oct 26.
Results Reference
derived
Learn more about this trial
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
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