Skip to main content
Clinical Trials/NCT01785576
NCT01785576
Completed
N/A

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

NorthShore University HealthSystem1 site in 1 country20 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
NorthShore University HealthSystem
Enrollment
20
Locations
1
Primary Endpoint
Quality of Life
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
October 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rachel Pulido

Asst Director, Research Compliance

NorthShore University HealthSystem

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

Outcomes

Primary Outcomes

Quality of Life

Time Frame: 6 months

Secondary Outcomes

  • Spousal Support(6 months)

Study Sites (1)

Loading locations...

Similar Trials