Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Yoga Program for Couples Coping With Cancer
2 other identifiers
interventional
600
1 country
1
Brief Summary
This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Taking part in yoga or stretching sessions may lower distress, improve quality of life, and/or may improve sleep and fatigue for cancer patients and their caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
January 12, 2026
January 1, 2026
7.9 years
May 20, 2020
January 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)
This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) modeling (MLM) analysis, with repeated measures over time (i.e., at end of treatment, 3- and 6-month follow-ups). Potential interaction terms will be included and tested, in particular, between the intervention and time. The repeated measures correlation structure will be selected using the Bayesian information criterion (BIC). The difference between dyadic yoga (DY) and waitlist control (WLC) at 3MFU is considered the primary and confirmatory comparison and will be tested at a two-sided 0.025 significance level. Additionally, on an exploratory basis, will conduct an omnibus test on the overall differences in 6MWT across the three groups at 3-month follow-up, as well as pairwise comparisons between the patient yoga (PY) and WLC and between DY and PY. Exploratory comparisons will be primarily interpreted based on clinically significant difference, which is 70m for the study population.
At the 3-month follow-up
Secondary Outcomes (1)
Patient and partner short form survey (SF-36) domains
At each follow-up time point (1 month follow-up to 6-month follow-up)
Other Outcomes (3)
Healthcare utilization and work productivity
During radiation therapy (RT) and 90-days post-RT (T1-T5)
Physical and emotional intimacy
Baseline, end of treatment (T3), 3 months after RT (T5) and 6 months after RT (T6)
Treatment efficacy
At the end of radiation therapy (T2)
Study Arms (3)
Group I (DY)
EXPERIMENTALPatients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.
Group II (PY)
EXPERIMENTALPatients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.
Group III (WLC)
EXPERIMENTALPatients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
Interventions
Receive usual care
Ancillary studies
Participate in yoga sessions
Eligibility Criteria
You may qualify if:
- PATIENTS ONLY: Diagnosed with a lung cancer, head and neck cancer, or esophageal cancer to receive at least 25 fractions over 5 weeks of radiation therapy (RT)
- PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- PATIENTS ONLY: Having a spouse or cohabitating partner (same or opposite sex) willing to participate
- PATIENTS AND PARTNERS: Must be at least 18 years old
- PATIENTS AND PARTNERS: Must be able to read and speak English
- PATIENTS AND PARTNERS: Must be able to provide informed consent
You may not qualify if:
- PATIENTS ONLY: Who have regularly (self-defined) participated in a mind-body practice or exercise program in the year prior to diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrin Milbury
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
October 29, 2020
Study Start
May 31, 2019
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01