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

NCT03114501 | Active Not Recruiting

• 2 other identifiers: 2016-1127NCI-2018-01163
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer; Malignant Neoplasms of Lip Oral Cavity and Pharynx

Keywords

Malignant neoplasms of lip oral cavity and pharynx; Head and Neck Cancer; Yoga; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)

  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.

  6 weeks after radiation therapy

Secondary Outcomes (1)

• Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)

  6 weeks after radiation therapy

Study Arms (2)

Yoga Program Group

EXPERIMENTAL

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).

Behavioral: Yoga; Behavioral: Yoga Questionnaire; Behavioral: Symptom Questionnaires

Waitlist Control Group (WLC)

EXPERIMENTAL

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.

Behavioral: Symptom Questionnaires

Interventions

Yoga BEHAVIORAL

Participants receive yoga sessions up to 5 days per week, based on the patient's schedule, over the course of patients' Radiation Therapy (up to 15 sessions, 45-60 min. each). Yoga sessions audio and video recorded.

Yoga Program Group

Yoga Questionnaire BEHAVIORAL

Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.

Also known as: Survey

Yoga Program Group

Symptom Questionnaires BEHAVIORAL

Symptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Also known as: Surveys

Waitlist Control Group (WLC); Yoga Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Yoga; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kathrin Milbury, MA,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: April 11, 2017
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)