Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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) - PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 - PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) willing to participate - 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


NCT ID:

NCT03948100


Primary Contact:

Principal Investigator
Kathrin Milbury
M.D. Anderson Cancer Center

Kathrin Milbury
Phone: 713-745-2868
Email: kmilbury@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Kathrin Milbury
Phone: 713-745-2868

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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