Clinical trial NCT02409485: Improving Self-Management in Head and Neck Cancer
Official title: Improving Self-Management in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: self-management
head and neck cancer
psychosocial intervention
couples
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), this couple-based psychosocial 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 intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.

Detailed description: 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. The investigators 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 the 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). The investigators expect that most couples (\> 60%) approached will agree to participate and that CST will be well-accepted (AIM 2). 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.

Eligibility criteria: Inclusion Criteria:

* patient is initiating radiotherapy for HNC
* patient has Karnofsky score \> 50 (ambulatory \& capable of self-care)
* patient lives with a partner (spouse/significant other - includes homo- and heterosexual couples)
* patient/partner is able to provide informed consent
* patient/partner is \> age 18.

Exclusion Criteria:

* patient has significant comorbidities (e.g., HIV, transplant), or another illness that may require hospitalization
* patient/partner cannot read or communicate using spoken English.
* individuals with diminished mental capacity
* prisoners
* pregnant women

Primary outcomes:
measure: Feasibility of the CST intervention as assessed by recruitment and retention rates
timeFrame: 6 months
measure: Acceptability of the CST intervention as assessed by the program evaluation questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: PROMIS short form anxiety and depression
timeFrame: 6 months
measure: Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
timeFrame: 6 months
measure: Partners QOL measured by Short Form 12 (SF12)
timeFrame: 6 months
measure: Short Form Dyadic Adjustment Scale (DAS7)
timeFrame: 6 months
measure: Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Hoda Badr, PhD
role: PRINCIPAL_INVESTIGATOR
References: