Yoga for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Regular yoga, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

236 Participants Needed

Trial Summary

What is the purpose of this trial?

Objectives: Primary Aim: Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients undergoing radiotherapy (RT) and their family caregivers. Secondary Aims: 1. Establish the initial efficacy of the yoga program in patients and their caregivers regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and grip strength).

Research Team

Kathrin Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with head and neck cancer who are about to undergo at least 4 weeks of radiotherapy. They must be able to consent, have a performance status of 2 or lower, speak English, and not practice yoga regularly before diagnosis. A family caregiver willing to join the yoga sessions is also required.

Inclusion Criteria

I can take care of myself but cannot do heavy physical work.

I have head or neck cancer and will undergo radiation therapy for at least 4 weeks.

Able to provide informed consent

Exclusion Criteria

Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team

You have been regularly practicing yoga in the year before being diagnosed.

Those who participate in phase 1 are ineligible to participate in phase 2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy while participating in the dyadic yoga program or completing questionnaires

6 weeks

Weekly visits for radiation therapy and yoga sessions

Yoga Program

Participants in Group 1 take part in up to 15 yoga sessions during radiation therapy

6 weeks

Up to 15 yoga sessions, either in-person or via videoconferencing

Follow-up

Participants are monitored for quality of life and other outcomes after completion of radiation therapy

6 weeks

Questionnaires completed 6 weeks after radiation therapy

Treatment Details

Interventions

• Dyadic Yoga Intervention

Trial Overview The study tests a dyadic yoga program's feasibility for patients with head and neck cancer undergoing radiotherapy and their caregivers. It looks at how this program might affect quality of life, including fatigue, sleep issues, mood, physical strength (like grip), and overall well-being.

Participant Groups

Group I: Yoga Program Group Experimental Treatment 3 Interventions

Participants take part in the partner-based yoga program. Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions. Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Group II: Waitlist Control Group (WLC) Experimental Treatment 1 Intervention

Participants receive standard of care. Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later). After the study has been completed, participant and caregiver/alternative caregiver offered the opportunity to take part in the partner-based yoga program.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+