Hatha Yoga in Lung Cancer Couples

NCT01952860 | Terminated

• 1 other identifier: 2013-0496
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Non-small cell lung cancer; NSCLC; Caregiving partner; Hatha Yoga; Radiation therapy; XRT; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Study Arms (1)

Hatha Yoga

EXPERIMENTAL

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; Behavioral: Questionnaires

Interventions

Hatha Yoga OTHER

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.

Hatha Yoga

Questionnaires BEHAVIORAL

Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.

Also known as: Surveys

Hatha Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kathrin Milbury, PHD, MA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 30, 2013
• Study Start: September 23, 2013
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

US (1)