Clinical Trial: Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

Brief Summary:

The goal of this behavioral research study is to learn if a partner-based yoga program can be used during treatment for cancer, and to learn the opinion of patients and their caregivers about the program. Caregivers can be informal family caregivers such as spouse, romantic partner, adult child, or sibling, and if needed, an alternate caregiver can rotate in if the first one is unavailable to attend. If participant is an alternate caregiver, participant will be asked to sign this consent form as well.

If the patient participant is caring for does not agree to take part in this study, participant cannot take part.

Researchers also want to learn if and how this program affects any fatigue, sleep difficulties, depression symptoms, and overall quality of life.

For comparison purposes, some participants will be assigned to take part in this program and others will not complete the program.


Detailed Summary:

If participant agrees to take part in this study, participant's demographic information (such as participant's age, sex, and race) will be recorded at participant's first visit.

After participant's first visit, participant and the patient will be assigned to 1 of 2 groups. Participant will either automatically be assigned to Group 1 if participant is in the first 10 couples to join the study, or participant 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. Participant has 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 participant is in Group 1, participant will take part in the partner-based yoga program.

If participant is in Group 2, participant will not take part in the partner-based yoga program but will complete the same questionnaires as Group 1. After the study has been completed, participant and the patient will be offered the opportunity to take part in the partner-based yoga program. This will be offered outside the study and will be offered at no cost to participant.

Group 1 - Yoga Sessions and Alternate Caregiver Questionnaire:

If participant is in Group 1, participant will take part in up to 15 sessions of yoga over the course of the patient's radiation therapy. Each 45- to 60-minute session will be guided by an instructor. Participant should attend each session together as partners.

During the yoga sessions, participant will
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT) [ Time Frame: 6 weeks after radiation therapy ]

Efficacy of the yoga program determined by responses on quality of life (QOL) questionnaires.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 11, 2017
Date Started: April 11, 2017
Date Completion: April 2020
Last Updated: April 19, 2017
Last Verified: April 2017