Dyadic Yoga Intervention 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

Not Applicable

Recruiting

• Conditions: Stage IIIA Lung Cancer AJCC v8; Esophageal Carcinoma; Stage I Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8
• Interventions: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Yoga

• Registration Number: NCT03948100
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)
• PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• PATIENT ONLY: Able to read, write and speak English
• PATIENT ONLY: Able to provide informed consent
• PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.

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Exclusion Criteria

• PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis
• PATIENT ONLY: Patients who metastatic disease involving the central nervous system

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (dyadic education)	Quality-of-Life Assessment	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.
Group II (dyadic education)	Questionnaire Administration	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.
Group I (dyadic yoga)	Quality-of-Life Assessment	Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.
Group I (dyadic yoga)	Yoga	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)	Educational Intervention	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.
Group I (dyadic yoga)	Questionnaire Administration	Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.

Primary Outcome Measures

Name	Time	Method
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 edication (DE) at 3 month follow-up (3MFU) will be tested at a two-sided .05 significance level.

Secondary Outcome Measures

Name	Time	Method
Patient and caregiver quality of life (QOL)	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States