Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-III Non-small Cell Lung Cancer Undergoing Radiotherapy and Their Caregivers
Study Details
Study Description
Brief Summary
This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-III non-small cell lung cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and/or their caregivers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- To examine the extent to which the yoga program improves patient physical performance (i.e., 6-minute walk test [6MWT]) as compared to the education group.
SECONDARY OBJECTIVES:
- To examine the extent to which the yoga program improves patient and caregiver quality of life (QOL) (SF-36) compared to the education group.
TERTIARY OBJECTIVES:
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To explore if, compared to the education group, the yoga program improves symptom burden, reduces inflammatory cytokine and cortisol rhythmicity dysregulation, and improves dyadic symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.
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To explore if baseline factors such as depressive symptoms moderate the treatment response.
QUALITATIVE OBJECTIVES:
- To understand the patient and caregiver experience of cancer, cancer treatment, and experience in the behavioral interventions, and explore emerging themes as possible mediators.
OUTLINE: Patients and caregivers are assigned to 1 of 2 groups.
GROUP I: Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
GROUP II: Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.
After completion of study, patients and caregivers are followed up every 2 weeks for 3 months and then every month for up to 6 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (dyadic yoga) Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions. |
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Yoga
Undergo dyadic yoga
Other Names:
|
| Active Comparator: Group II (dyadic education) Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions. |
Other: Educational Intervention
Undergo dyadic education program
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Patient 6-minute walk test (6MWT) [At 3 months post study]
Descriptive statistics for study variables and potential covariates will be computed and distribution characteristics of the variables will be examined. The difference between dyadic yoga (DY) and dyadic education (DE) at 3 month follow-up (3MFU) will be tested at a two-sided .05 significance level.
Secondary Outcome Measures
- Patient and caregiver quality of life (QOL) measured with the Medical Outcomes Study 36-item short-form survey (SF-36) Patient and caregiver quality of life (QOL) measured with the Medical Outcomes Study 36-item short-form survey (SF-36 [Up to 6 months post study]
Analyses will be similar to those for the primary outcome, except that we will use a dyadic model assuming additional dependence in outcomes between patient and caregiver outcomes.
Other Outcome Measures
- Mediation effect [At 3 months post study]
Patient and caregiver symptoms assessed with the MD Anderson Symptom Inventory (MDASI).
- Inflammatory Cytokines [At 3 months post study]
Will be assessed with blood samples.
- Cortisol rhythmicity [At 3 months post study]
Will be assessed via saliva samples.
- Dyadic Symptom Management [At 3 months post study]
Will be assessed with the Couples' Illness Communication Scale (CICS)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
PATIENT ONLY: Diagnosed with stage I-III non-small cell lung cancer (NSCLC) and going to receive at least 5 weeks of thoracic radiotherapy (RT)
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PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) willing to participate
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PATIENT AND CAREGIVER: Able to read, write and speak English
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PATIENT AND CAREGIVER: Able to provide informed consent
Exclusion Criteria:
- PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0503
- NCI-2018-03913
- 2018-0503