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

Overview

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.

Full Title of Study: “Dyadic Behavioral Interventions to Manage Physical Performance, Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2025

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. 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. 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.

Interventions

  • Other: Educational Intervention
    • Undergo dyadic education program
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Questionnaire Administration
    • Ancillary studies
  • Procedure: Yoga
    • Undergo dyadic yoga

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Patient and caregiver quality of life (QOL)
    • 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.

Participating in This Clinical Trial

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: 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. – PATIENT AND CAREGIVER: Able to read, write and speak English – 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 – PATIENT ONLY: Patients who metastatic disease involving the central nervous system

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathrin Milbury, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Kathrin Milbury, 713-745-2868, kmilbury@mdanderson.org

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