Clinical trial NCT04890834: 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
Official title: Improving Healthcare Utilization and Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient healthcare utilization (Standard of care)
timeFrame: Up to 6 months with 3 months follow-up
Secondary outcomes:
measure: Caregiver quality of life questionnaire (RAND 36-Item Health Survey)
timeFrame: Up to 6 months with 3 months follow-up
measure: Patient quality of life questionnaire
timeFrame: Up to 6 months with 3 months follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathrin Milbury
role: PRINCIPAL_INVESTIGATOR
References: