Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
couples, head and neck cancer, oncology, spousal support
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Couple-Based CBT Intervention
Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
NorthShore University HealthSystem
Evanston, Illinois, United States
Status: Recruiting
Start Date
March 2013
Completion Date
July 2015
Sponsors
NorthShore University HealthSystem Research Institute
Source
NorthShore University HealthSystem Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page