Patients treated with radiation (XRT) for head and neck cancers (HNCs) experience significant side effects such as abnormally reduced salivation, difficulty swallowing, and taste changes even after they have been definitively treated. To control side effects and minimize discomfort, intensive self-care protocols are prescribed, but adherence is poor. Partners (spouses/significant others) can play a critical role in supporting adherence, but often lack knowledge, experience high rates of distress, and display poor communication (e.g., critical or controlling), that can interfere with patient self-care. We have developed a home-based couples skills-training (CST) intervention that teaches: 1) self-management skills to control/prevent side-effects~ 2) communication skills to facilitate coordination of care and support~ and 3) strategies to improve communal coping and confidence in the ability to work as a team. The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL.
Specific aims are to: develop and evaluate the content and materials of the CST intervention (AIM 1) and evaluate its feasibility and acceptability (AIM 2). The multidisciplinary team will review and evaluate the content we have already developed based on our ongoing work with HNC couples (K07). Once content is finalized, tailored manuals will be developed for patients and partners and evaluated through two focus groups (AIM 1). Sixty couples will then be recruited before the patient starts XRT (baseline) and randomly assigned to the CST condition (tailored manuals + 6 telephone counseling sessions), or usual medical care (UMC). We expect that most couples (>60%) we approach will agree to participate and that CST will be well-accepted (AIM 2). Although this pilot is not designed to test for group differences, we expect: 1) patients receiving CST will have less healthcare utilization during XRT (e.g., fewer unplanned clinic visits), and better physical QOL (e.g., less weight loss, symptom burden) at the 1, 3, and 6 month follow-ups than patients receiving UMC~ and, 2) patients and partners receiving CST will experience better relationship functioning and less emotional distress (e.g., depression and anxiety symptoms) at the follow-ups than those receiving UMC. Knowledge gained will be used to refine CST and to collect data on effect sizes and variation for a larger trial. Innovation: CST takes a multiple-behavioral approach to addressing and preventing HNC treatment side effects and, in the process, seeks to improve multiple domains of QOL. It is also the first program in HNC that actively involves both members of the couple to address barriers in the home environment in which self-management occurs. Finally, this study conceptualizes the couple relationship as a resource and leverages that resource to improve patient care and outcomes. Impact: Home-based delivery will enhance future dissemination and outreach to the target population. Overall, CST holds great promise for improving patient self-management behaviors, reducing costly hospitalizations and treatment interruptions, and improving multiple aspects of patient and partner QOL.

Public Health Relevance

By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), the proposed intervention holds great promise for improving self-management, reducing costly hospitalizations and treatment interruptions, and improving both partners'quality of life. Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers. If found effective, the proposed intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.

Agency
National Institute of Health (NIH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA178478-01A1
Application #
8752355
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Padgett, Lynne S
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10029