Clinical trial NCT01785576: Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Official title: Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: couples
head and neck cancer
oncology
spousal support
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Spousal Support
timeFrame: 6 months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Tina Gremore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.