Dyadic Yoga Intervention for the Improvement of Healthcare Utilization and Quality of Life in Patients With Head and Neck Cancer Undergoing Chemoradiation and Their Caregivers

NCT04890834 | Active Not Recruiting

• 3 other identifiers: 2020-0311NCI-2020-13884R01CA247307
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Patient healthcare utilization (Standard of care)

  Will examine group differences in patient emergency department visit (yes/no) during the observation period of during and up to 3 months post chemoradiotherapy (CRT) as the primary outcome. Will use logistic regression with the randomization factors as covariates, as these factors may be associated with the study outcomes, and controlling for them is likely to increase the power to detect the between-group differences.

  Up to 6 months with 3 months follow-up

Secondary Outcomes (2)

• Caregiver quality of life questionnaire (RAND 36-Item Health Survey)

  Up to 6 months with 3 months follow-up

• Patient quality of life questionnaire

  Up to 6 months with 3 months follow-up

Study Arms (2)

Arm I (Standard of care)

ACTIVE COMPARATOR

Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.

Other: Best Practice; Other: Questionnaire Administration

Arm II (exercise, yoga sessions)

OTHER

Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.

Other: Best Practice; Other: Exercise Intervention; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

Arm I (Standard of care); Arm II (exercise, yoga sessions)

Exercise Intervention OTHER

Participate in yoga sessions

Arm II (exercise, yoga sessions)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Standard of care); Arm II (exercise, yoga sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENTS: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
• PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
• PATIENTS AND CAREGIVERS: Must be at least 18 years old
• PATIENTS AND CAREGIVERS: Able to read and speak English
• PATIENTS AND CAREGIVERS: Able to provide informed consent

You may not qualify if:

• PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Kathrin Milbury

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: May 18, 2021
• Study Start: January 28, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)