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Hatha Yoga in Lung Cancer Couples

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha Yoga
Questionnaires
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung Cancer, Non-small cell lung cancer, NSCLC, Caregiving partner, Hatha Yoga, Radiation therapy, XRT, Questionnaires, Surveys

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with non-small cell lung cancer (NSCLC) stages I through IIIB who are going to receive at least 5 weeks of thoracic radiation therapy with or without chemotherapy undergoing daily radiation treatment in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and an eligible and consenting caregiving partner.
  2. Patients and caregiving partners must both be at least 18 years old.
  3. Participants have a study eligible and consenting caregiving partner spouse or significant other (e.g, romantic partner). (i.e. spouse, romantic/domestic partners, significant others).
  4. Patients and caregiving partners should be able to read, write, and speak English.

Exclusion Criteria:

  1. Patients who are not oriented to time, place, and person.
  2. Patients who have practiced Tibetan or Hatha yoga in the year prior to diagnosis on a regular basis.
  3. Lung cancer patients with a life expectancy of less than 6 months per attending physician estimation.
  4. Lung cancer patients with the attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2 at the time of radiotherapy initiation.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hatha Yoga

Arm Description

Participants receive 18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home. Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.

Outcomes

Primary Outcome Measures

Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by attendance
If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible.
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by questionnaire responses.
If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible. European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer-specific Quality of Life Questionnaire (QLQ-LC13) used for the follow-up assessment.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2013
Last Updated
December 31, 2019
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01952860
Brief Title
Hatha Yoga in Lung Cancer Couples
Official Title
A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Requested by PI during yearly Continuing Review
Study Start Date
September 23, 2013 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research study is to learn the opinion of patients and their caregiving about a couple-based Hatha Yoga program during treatment for cancer. Researchers also want to learn the effect of this program on lung function, distress, and quality of life.
Detailed Description
If participant agrees to take part, participant's medical history and demographic information (such as age, sex, and race) will be recorded. By signing this consent, participant also agrees that participant's caregiving partner will be approached to take part in this study. Questionnaires: Participant will complete about 10 questionnaires before participant's first radiation treatment and again after participant completes participant's treatment schedule (usually 6 weeks later). The questionnaires ask about participant's health, any symptoms participant may be having, participant's mood, participant's level of fatigue, participant's sleeping habits, participant's relationship, and participant's quality of life. It should take about 45 minutes to complete these questionnaires. Participant will complete about 5 questionnaires again halfway through participant's radiation treatment schedule. These questionnaires ask about participant's quality of life. These should take about 20 minutes to complete. During each week of radiation therapy, participant will also complete a questionnaire asking participant's feelings about the Hatha Yoga sessions. Participant will be asked to list what participant liked or disliked, what participant found most and least useful, and how participant would rate the instructor. Participant will also be asked about how often participant practices outside of class and if participant thinks they are benefitting from the Hatha Yoga program. It should take about 5 minutes to answer this questionnaire. Participant's answers to the questions will not be shared with participant's caregiving partner. Hatha Yoga Sessions: Participant will take part in up to 18 sessions of Hatha yoga over the course of radiation therapy. Each 45- to 60-minute session will be guided by an instructor. Participant should attend each session together as a couple. During the yoga sessions, participant will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and participant will sit on the floor or in a chair while participant does them. Participant can move through the exercises at participant's own pace. The instructor will be available to answer any questions participant may have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to view this videotape. The video files are digital and will be deleted after all the data are studied. At participant's first session, participant will be given a CD and instructions for practicing Hatha yoga at home. While participant is receiving radiation therapy, participant will be asked to practice at home 1 time a day either with participant's caregiving partner or alone on the days participant does not have a session at the clinic. Length of Study: Participation on this study will be over when participant has completed the questionnaires during participant's last week of radiation therapy. This is an investigational study. Up to 15 patients and their caregiving partners, for a total of 30 participants, will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Non-small cell lung cancer, NSCLC, Caregiving partner, Hatha Yoga, Radiation therapy, XRT, Questionnaires, Surveys

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hatha Yoga
Arm Type
Experimental
Arm Description
Participants receive 18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home. Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
Intervention Type
Other
Intervention Name(s)
Hatha Yoga
Intervention Description
18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
Primary Outcome Measure Information:
Title
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by attendance
Description
If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible.
Time Frame
6 weeks
Title
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by questionnaire responses.
Description
If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible. European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer-specific Quality of Life Questionnaire (QLQ-LC13) used for the follow-up assessment.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with non-small cell lung cancer (NSCLC) stages I through IIIB who are going to receive at least 5 weeks of thoracic radiation therapy with or without chemotherapy undergoing daily radiation treatment in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and an eligible and consenting caregiving partner. Patients and caregiving partners must both be at least 18 years old. Participants have a study eligible and consenting caregiving partner spouse or significant other (e.g, romantic partner). (i.e. spouse, romantic/domestic partners, significant others). Patients and caregiving partners should be able to read, write, and speak English. Exclusion Criteria: Patients who are not oriented to time, place, and person. Patients who have practiced Tibetan or Hatha yoga in the year prior to diagnosis on a regular basis. Lung cancer patients with a life expectancy of less than 6 months per attending physician estimation. Lung cancer patients with the attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2 at the time of radiotherapy initiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathrin Milbury, PHD, MA
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Hatha Yoga in Lung Cancer Couples

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