Condition or disease | Intervention/treatment | Phase |
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Caregiver Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 | Other: Educational Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Yoga | Not Applicable |
PRIMARY OBJECTIVES:
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 OBJECTIVES:
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.
QUALITATIVE OBJECTIVES:
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.
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Dyadic Behavioral Interventions to Manage Physical Performance Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers |
Actual Study Start Date : | December 20, 2018 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
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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.
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Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration Ancillary studies
Procedure: Yoga Undergo dyadic yoga
Other Name: Yoga Therapy
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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.
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Other: Educational Intervention
Undergo dyadic education program
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration Ancillary studies
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathrin Milbury | 713-745-2868 | kmilbury@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kathrin Milbury 713-745-2868 | |
Principal Investigator: Kathrin Milbury |
Principal Investigator: | Kathrin Milbury | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | April 5, 2019 | ||||
First Posted Date ICMJE | May 13, 2019 | ||||
Last Update Posted Date | July 23, 2020 | ||||
Actual Study Start Date ICMJE | December 20, 2018 | ||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patient 6-minute walk test (6MWT) [ Time Frame: 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: 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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | Dyadic Behavioral Interventions to Manage Physical Performance Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers | ||||
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. | ||||
Detailed Description |
PRIMARY OBJECTIVES: 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 OBJECTIVES: 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. QUALITATIVE OBJECTIVES: 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. 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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
400 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03948100 | ||||
Other Study ID Numbers ICMJE | 2018-0503 NCI-2018-03913 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0503 ( Other Identifier: M D Anderson Cancer Center ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |