- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785576
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners (CoupleCare)
July 19, 2019 updated by: Rachel Pulido, NorthShore University HealthSystem
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Evanston, Illinois, United States, 60201
- NorthShore University Healthsystem
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Couple-Based CBT Intervention
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
|
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
|
No Intervention: Treatment as Usual
The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spousal Support
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tina Gremore, PhD, NorthShore University Healthsystem
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 5, 2013
First Submitted That Met QC Criteria
February 5, 2013
First Posted (Estimate)
February 7, 2013
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 19, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH12-140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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