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Active Not Recruiting NCT03114501

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

Conditions: Malignant Neoplasms of Lip Oral Cavity and Pharynx, Head and Neck Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 236
Sponsor: M.D. Anderson Cancer Center

Location: University of Texas MD Anderson Cancer Center Houston Texas

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).

Eligibility Criteria

Inclusion Criteria: 1. (Patients) Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions 2. (Patients) ECOG performance status of 2 or lower 3. (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. 4. (Patients) having a smart phone (phase 2 only) 5. (Patients and Caregivers) must be (1) at least 18 years old 6. (Patients and Caregivers) able to read and speak English 7. (Patients and Caregivers) able to provide informed consent Exclusion Criteria: 1. (Patients) regularly (self-defined) participated in a yoga practice in the year prior to diagnosis 2. (Patients) cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team 3. (Patients and Caregivers) those who participate in phase 1 are ineligible to participate in phase 2

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03114501). StuddyBuddy aggregates publicly available trial information.