Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Carcinoma
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Lung Non-Small Cell Carcinoma
  • Stage I Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IB 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
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

NCT number NCT03948100
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Kathrin Milbury
Phone 713-745-2868
Email kmilbury@mdanderson.org
Status Recruiting
Phase N/A
Start date December 20, 2018
Completion date April 30, 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT04267913 - Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial) Phase 2
Recruiting NCT04151940 - PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer N/A
Terminated NCT03707925 - Bronchoscopic Laser Ablation of Peripheral Lung Tumors N/A
Active, not recruiting NCT04081688 - Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC Phase 1
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Recruiting NCT04250545 - Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer Phase 1
Terminated NCT04396535 - Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Withdrawn NCT05161533 - Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial Phase 2
Recruiting NCT04919369 - All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Terminated NCT03662074 - Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT04073745 - Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer Phase 1
Withdrawn NCT04186988 - [18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy Early Phase 1
Active, not recruiting NCT03600701 - Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03637816 - Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05234307 - PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06122064 - A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer N/A
Active, not recruiting NCT04533451 - Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03731585 - Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment N/A