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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03913 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0503 | Other Identifier | M D Anderson Cancer Center | |
| R37CA231522 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal 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.
PRIMARY OBJECTIVE:
I. 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 OBJECTIVE:
I. 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:
I. 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.
II. To explore if baseline factors such as depressive symptoms moderate the treatment response. We also seek to explore if baseline factors such as depressive symptoms moderate the treatment response.
QUALITATIVE OBJECTIVE:
I. To understand the patient and caregiver experience of cancer, cancer treatment, and experience in the behavioral interventions, and explore emerging themes as possible mediators. We would also like to understand participants feedback on participating in this intervention via mobile application (app) delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (dyadic yoga) | Experimental | 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 (dyadic education) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Undergo dyadic education program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient 6-minute walk test (6MWT) | 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 edication (DE) at 3 month follow-up (3MFU) will be tested at a two-sided .05 significance level. | At 3 months post study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and caregiver quality of life (QOL) | 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. | Up to 6 months post study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathrin Milbury | Contact | 713-745-2868 | kmilbury@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Kathrin Milbury | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34036820 | Derived | Snyder S, Silva RF, Whisenant MS, Milbury K. Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019111. doi: 10.1177/15347354211019111. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Research staff blinded to group assignment will collect the assessments
| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Yoga | Procedure | Undergo dyadic yoga |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D015013 | Yoga |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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