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Yoga Program for Lung Cancer Patients and Caregivers

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ClinicalTrials.gov Identifier: NCT02196844
Recruitment Status : Unknown
Verified December 2019 by M.D. Anderson Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2014
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this behavioral research study is to learn the opinion of patients and their caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer. Researchers also want to learn the effect of this program on lung function, distress, biological function, and quality of life. For comparison purposes, there will also be a group of participants (Group 2) that does not take part in this program.

You and your caregiver/family member will have about a 50/50 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.


Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Hatha Yoga Behavioral: Questionnaires Other: Walk Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Couple-Based Yoga Program for Patients Receiving Thoracic Radiation and Their Family Caregivers
Actual Study Start Date : September 29, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Yoga Group
Couple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
Behavioral: Hatha Yoga
5-6 weeks of a couple-based yoga program, three sessions per week (up to 15 sessions) during radiation treatment.

Behavioral: Questionnaires
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later.
Other Name: Surveys

Other: Walk Test
6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.

Experimental: Wait-List Control Group

10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule, at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.

Participants given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet.

Behavioral: Questionnaires
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later.
Other Name: Surveys

Other: Walk Test
6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.

Experimental: Caregivers

Yoga Group - Caregivers: 5-6 weeks of yoga during patient's radiation treatment. At fifth session, caregiver given CD for practicing yoga at home. During each week of patient's radiation, caregiver completes questionnaire about their feelings about yoga sessions. 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation, at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after patient's radiation therapy.

Waitlist-Control Group - Caregivers: 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation. at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after radiation therapy.

Caregivers given option to take part in yoga program after they finish their last questionnaire packet.

Behavioral: Hatha Yoga
5-6 weeks of a couple-based yoga program, three sessions per week (up to 15 sessions) during radiation treatment.

Behavioral: Questionnaires
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later.
Other Name: Surveys




Primary Outcome Measures :
  1. Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers [ Time Frame: 6 weeks ]

    Feasibility determined by 3 criteria:

    1) accrual of sample within 2 years; 2) adherence, retention and satisfaction rates; and 3) no serious adverse events that are directly attributable to the intervention. Trial judged feasible if at least: 50% of eligible dyads agree to randomization and enroll, 70% of enrolled dyads complete the study and at least 10 yoga sessions have been attended, and 75% of participants rate the program as "useful" or "very useful". Study conditions recruitment rate, drop-out rates, and completion rates calculated along with 95% confidence intervals (CI).




Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with lung or esophageal cancer stages I through IIIB who are going to receive at least 5 weeks of daily thoracic radiation therapy with or without chemotherapy in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and have an eligible and consenting family caregiver living with the patient while he/she receives treatment (i.e., adult child, sibling, parent).
  2. Patients and caregivers must both be at least 18 years old and able to give informed consent.
  3. Patients and caregivers must be able to read, write, and speak English.
  4. Patient and caregiver must be willing to be videotaped.

Exclusion Criteria:

  1. Patients and caregivers who are not oriented to time, place, and person.
  2. Patients who have regularly practiced yoga in the year prior to recruitment.
  3. Patients who have an ECOG performance status score greater than 2 at time of recruitment.

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): NCT02196844


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Kathrin Milbury, PHD, MA M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02196844    
Other Study ID Numbers: 2014-0036
1K01AT007559-01A1 ( U.S. NIH Grant/Contract )
NCI-2015-01902 ( Other Identifier: NCI CTRP )
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Lung cancer
Hatha Yoga
Questionnaires
Surveys
Walk Test
Caregiver
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases