Improving Self-Management in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Improving Self-Management in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409485
• Other study ID #: GCO 12-1641
• Secondary ID: R21CA178478H-487
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 2019

Study information

• Verified date: January 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• Couples Skill-Training (CST)
Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist. Manual content is tailored based on role (patient or partner). Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the CST intervention as assessed by recruitment and retention rates	recruitment and retention rates	6 months
Primary	Acceptability of the CST intervention as assessed by the program evaluation questionnaire	satisfaction with the intervention by completing a program evaluation questionnaire developed by the study team that asks about perceived skills mastery and satisfaction with program content and logistics	6 months
Secondary	PROMIS short form anxiety and depression	measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression	6 months
Secondary	Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)	measures QOL for patients	6 months
Secondary	Partners QOL measured by Short Form 12 (SF12)	measures QOL for partners	6 months
Secondary	Short Form Dyadic Adjustment Scale (DAS7)	measures Relationship functioning	6 months
Secondary	Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits	number of hospitalizations and unplanned clinic visits	6 months