Clinical trial · Interventional
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
NCT03114501CI-TRIAL-00108280active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasms of Lip Oral Cavity and Pharynx | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symptom Questionnaires | Behavioral | — | UNRESOLVED |
| Yoga | Behavioral | — | UNRESOLVED |
| Yoga Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Yoga Program Group
- description
- 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).
- interventionNames
- Behavioral: Yoga
- Behavioral: Yoga Questionnaire
- Behavioral: Symptom Questionnaires
- type
- EXPERIMENTAL
- label
- Waitlist Control Group (WLC)
- description
- 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.
- interventionNames
- Behavioral: Symptom Questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMilbury K, Rosenthal DI, Li Y, Ngo-Huang AT, Mallaiah S, Yousuf S, Fuller CD, Lewis C, Bruera E, Cohen L. Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers. J Pain Symptom Manage. 2024 Jun;67(6):490-500. doi: 10.1016/j.jpainsymman.2024.02.565. Epub 2024 Mar 5. PMID 38447621