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

Improving Healthcare Utilization and Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation and Their Family Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Exercise Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.

II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.

III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.

IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathrin Milbury; Phone Number: 713-745-2868; Email: kmilbury@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Kathrin Milbury; Phone Number: 713-745-2868
      • Principal Investigator: Kathrin Milbury

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (Standard of care); 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: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard care; Other Names: standard of care; standard therapy
Other: Arm II (exercise, yoga sessions); 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: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard care; Other Names: standard of care; standard therapy; Other: Exercise Intervention; Participate in yoga sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver quality of life questionnaire (RAND 36-Item Health Survey)	Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate. Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)	Up to 6 months with 3 months follow-up
Patient quality of life questionnaire	Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate. Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)	Up to 6 months with 3 months follow-up

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2020-0311 (Other Identifier: M D Anderson Cancer Center); NCI-2020-13884 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA247307 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No