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出境医 / 临床实验 / 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

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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

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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kathrin Milbury M.D. Anderson Cancer Center
Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE December 20, 2018
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2019)
  • Mediation effect [ Time Frame: At 3 months post study ]
    Patient and caregiver symptoms assessed with the MD Anderson Symptom Inventory (MDASI).
  • Inflammatory Cytokines [ Time Frame: At 3 months post study ]
    Will be assessed with blood samples.
  • Cortisol rhythmicity [ Time Frame: At 3 months post study ]
    Will be assessed via saliva samples.
  • Dyadic Symptom Management [ Time Frame: At 3 months post study ]
    Will be assessed with the Couples' Illness Communication Scale (CICS)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Dyadic Behavioral Interventions to Manage Physical Performance Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
  • Procedure: Yoga
    Undergo dyadic yoga
    Other Name: Yoga Therapy
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Procedure: Yoga
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Snyder S, Silva RF, Whisenant MS, Milbury K. Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019111. doi: 10.1177/15347354211019111.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kathrin Milbury 713-745-2868 kmilbury@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948100
Other Study ID Numbers  ICMJE 2018-0503
NCI-2018-03913 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0503 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kathrin Milbury M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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