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Trial record 3 of 6 for:    milbury | lung cancer | United States
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948100
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 Other: Educational Intervention
Undergo dyadic education program
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Mediation effect [ Time Frame: At 3 months post study ]
    Patient and caregiver symptoms assessed with the MD Anderson Symptom Inventory (MDASI).

  2. Inflammatory Cytokines [ Time Frame: At 3 months post study ]
    Will be assessed with blood samples.

  3. Cortisol rhythmicity [ Time Frame: At 3 months post study ]
    Will be assessed via saliva samples.

  4. Dyadic Symptom Management [ Time Frame: At 3 months post study ]
    Will be assessed with the Couples' Illness Communication Scale (CICS)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948100


Contacts
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Contact: Kathrin Milbury 713-745-2868 kmilbury@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kathrin Milbury    713-745-2868      
Principal Investigator: Kathrin Milbury         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kathrin Milbury M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03948100    
Other Study ID Numbers: 2018-0503
NCI-2018-03913 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0503 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms