Hatha Yoga in Lung Cancer Couples

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01952860
First received: September 24, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Other: Hatha Yoga
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Analysis of data focused on assessing descriptive feasibility of the yoga program. 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.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Hatha Yoga
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.
Behavioral: Questionnaires
Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
Other Name: Surveys

Detailed Description:

If you agree to take part, your medical history and demographic information (such as your age, sex, and race) will be recorded. By signing this consent, you also agree that your caregiving partner will be approached to take part in this study.

Questionnaires:

You will complete about 10 questionnaires before your first radiation treatment and again after you complete your treatment schedule (usually 6 weeks later). The questionnaires ask about your health, any symptoms you may be having, your mood, your level of fatigue, your sleeping habits, your relationship, and your quality of life. It should take about 45 minutes to complete these questionnaires.

You will complete about 5 questionnaires again halfway through your radiation treatment schedule. These questionnaires ask about your quality of life. These should take about 20 minutes to complete.

During each week of radiation therapy, you will also complete a questionnaire asking your feelings about the Hatha Yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice outside of class and if you think you are benefitting from the Hatha Yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with your caregiving partner.

Hatha Yoga Sessions:

You 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. You should attend each session together as a couple.

During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you 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 your first session, you will be given a CD and instructions for practicing Hatha yoga at home. While you are receiving radiation therapy, you will be asked to practice at home 1 time a day either with your caregiving partner or alone on the days you do not have a session at the clinic.

Length of Study:

Your participation on this study will be over when you have completed the questionnaires during your 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952860

Contacts
Contact: Kathrin Milbury, PHD, MA 713-745-9202

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Kathrin Milbury, PHD, MA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01952860     History of Changes
Other Study ID Numbers: 2013-0496
Study First Received: September 24, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-small cell lung cancer
NSCLC
Caregiving partner
Hatha Yoga
Radiation therapy
XRT
Questionnaires
Surveys

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014