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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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 |
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 : | 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 |
| 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:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- 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.
- 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.
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| Contact: Kathrin Milbury | 713-745-2868 | kmilbury@mdanderson.org |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathrin Milbury 713-745-2868 | |
| Principal Investigator: Kathrin Milbury | |
| Principal Investigator: | Kathrin Milbury | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
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 |