Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Study Overview
Brief Summary
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).
Detailed Description
Caregiver:
If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded at your first visit.
After your first visit, you and the patient will be assigned to 1 of 2 groups. You will either automatically be assigned to Group 1 if you are in the first 10 couples to join the study, or you will be randomly assigned (as in the roll of dice) to Group 1 or Group 2.
This random assignment is done because no one knows if one study group is better, the same, or worse than the other group. You have about an equal chance of being assigned to each group. However, the assignment is also based on other factors such as age and disease status.
If you are in Group 1, you will take part in the partner-based yoga program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(Patients) Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions
- •(Patients) ECOG performance status of 2 or lower
- •(Patients) having an informal family caregiver (spouse, romantic partner, adult child, or sibling) who is willing to participate. If patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria.
- •(Patients) having a smart phone (phase 2 only)
- •(Patients and Caregivers) must be (1) 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) regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
- •(Patients) cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- •(Patients and Caregivers) those who participate in phase 1 are ineligible to participate in phase 2
Arms & Interventions
Waitlist Control Group (WLC)
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.
Intervention: Symptom Questionnaires (Behavioral)
Yoga Program Group
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).
Intervention: Yoga (Behavioral)
Yoga Program Group
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).
Intervention: Yoga Questionnaire (Behavioral)
Yoga Program Group
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).
Intervention: Symptom Questionnaires (Behavioral)
Outcomes
Primary Outcomes
Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Time Frame: 6 weeks after radiation therapy
Trial considered feasible if 1) ≥ 50% of eligible couples consent (i.e., approach 80 couples to obtain 40 consents); 2) ≥ 70% of enrolled couples complete both assessments; 3) on average ≥ 50% of all practice sessions are attended.
Secondary Outcomes
- Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)(6 weeks after radiation therapy)