Hatha Yoga in Lung Cancer Couples

December 31, 2019 updated by: M.D. Anderson Cancer Center

A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hatha Yoga
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.
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.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by attendance
Time Frame: 6 weeks
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.
6 weeks
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by questionnaire responses.
Time Frame: 6 weeks

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.

6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2013

Primary Completion (ACTUAL)

September 17, 2019

Study Completion (ACTUAL)

September 17, 2019

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (ESTIMATE)

September 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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