Yoga Program for Lung Cancer Patients and Caregivers

NCT02196844 | Completed DMC

• 3 other identifiers: 2014-00361K01AT007559-01A1NCI-2015-01902
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Hatha Yoga; Questionnaires; Surveys; Walk Test; Caregiver

Outcome Measures

Primary Outcomes (1)

• Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers

  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).

  6 weeks

Study Arms (3)

Yoga Group

EXPERIMENTAL

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; Behavioral: Questionnaires; Other: Walk Test

Wait-List Control Group

EXPERIMENTAL

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; Other: Walk Test

Caregivers

EXPERIMENTAL

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; Behavioral: Questionnaires

Interventions

Hatha Yoga BEHAVIORAL

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

Caregivers; Yoga Group

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Caregivers; Wait-List Control Group; Yoga Group

Walk Test OTHER

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

Wait-List Control Group; Yoga Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients and caregivers must both be at least 18 years old and able to give informed consent.
• Patients and caregivers must be able to read, write, and speak English.
• Patient and caregiver must be willing to be videotaped.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

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

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: September 29, 2014
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (1)