Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Couple-Based CBT Intervention

• Registration Number: NCT01785576
• Lead Sponsor: NorthShore University HealthSystem

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 Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Study Start: 2013-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Couple-Based CBT Intervention	Couple-Based CBT Intervention	Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

Primary Outcome Measures

Name	Time	Method
Quality of Life	6 months

Secondary Outcome Measures

Name	Time	Method
Spousal Support	6 months

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States