Yoga Program for Improving the Quality of Life in Couples Coping With Cancer

Yoga Program for Couples Coping With Cancer

This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Taking part in yoga or stretching sessions may lower distress, improve quality of life, and/or may improve sleep and fatigue for cancer patients and their caregivers.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm; Lung Carcinoma; Esophageal Carcinoma; Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Procedure: Quality-of-Life Assessment; Procedure: Yoga

Detailed Description

PRIMARY OBJECTIVE:

I. To examine the extent to which the dyadic yoga (DY) program improves patient objective physical performance as compared to the waitlist control (WLC) group (primary comparison) and the patient-only yoga (PY) group (exploratory comparison).

SECONDARY OBJECTIVE:

I. To examine the extent to which the DY program improves patient and partner quality of life (QOL) compared to the WLC group (primary comparison) and the PY group (exploratory comparison).

TERTIARY OBJECTIVE:

I. To examine the extent to which the DY program reduces patient healthcare utilization (i.e., emergency room visits, hospital admissions, and feeding tube insertions) and patient and partner work productivity compared to the WLC group (primary comparison) and the PY group (exploratory comparison).

EXPLORATORY OBJECTIVE:

I. To explore if, compared to the WLC and PY groups, the DY program improves symptom burden and symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I (DY): Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.

GROUP II (PY): Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners are offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.

GROUP III (WLC): Patients and their partner receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.

After completion of radiation therapy, patients are followed up at 1 , 2, 3, and 6 months.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Kathrin Milbury; Phone Number: 713-745-2868; Email: kmilbury@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer, head and neck cancer, or esophageal cancer scheduled to receive radiation therapy, who have a spouse or cohabitating partner.

Description

Inclusion Criteria:

• PATIENTS ONLY: Diagnosed with a lung cancer, head and neck cancer, or esophageal cancer to receive at least 25 fractions over 5 weeks of radiation therapy (RT)
• PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• PATIENTS ONLY: Having a spouse or cohabitating partner (same or opposite sex) willing to participate
• PATIENTS AND PARTNERS: Must be at least 18 years old
• PATIENTS AND PARTNERS: Must be able to read and speak English
• PATIENTS AND PARTNERS: Must be able to provide informed consent

Exclusion Criteria:

• PATIENTS ONLY: Who have regularly (self-defined) participated in a mind-body practice or exercise program in the year prior to diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (DY); Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.	Other: Questionnaire Administration; Ancillary studies; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Yoga; Participate in yoga sessions; Other Names: Yoga Therapy
Group II (PY); Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.	Other: Questionnaire Administration; Ancillary studies; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Yoga; Participate in yoga sessions; Other Names: Yoga Therapy
Group III (WLC); Patients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Yoga; Participate in yoga sessions; Other Names: Yoga Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)	This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) modeling (MLM) analysis, with repeated measures over time (i.e., at end of treatment, 3- and 6-month follow-ups). Potential interaction terms will be included and tested, in particular, between the intervention and time. The repeated measures correlation structure will be selected using the Bayesian information criterion (BIC). The difference between dyadic yoga (DY) and waitlist control (WLC) at 3MFU is considered the primary and confirmatory comparison and will be tested at a two-sided 0.025 significance level. Additionally, on an exploratory basis, will conduct an omnibus test on the overall differences in 6MWT across the three groups at 3-month follow-up, as well as pairwise comparisons between the patient yoga (PY) and WLC and between DY and PY. Exploratory comparisons will be primarily interpreted based on clinically significant difference, which is 70m for the study population.	At the 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and partner short form survey (SF-36) domains	Analyses will be similar to those for the primary outcome, except that will use a dyadic model assuming additional dependence in outcomes between patient and partner outcomes. Repeated measures over time will include at the end of treatment, 1-, 3- and 6-month follow-ups. Will examine the individual SF-36 domains as well as the physical (PCS) and mental component summaries (MCS). Patient and partner overall quality of life (QOL) will be measured with the Medical Outcomes Study 36-item short-form survey (SF-36) assessing 8 distinct domains: physical functioning, physical impediments to role functioning, pain, general health perceptions, vitality, social functioning, emotional impediments to role functioning, and mental health. The SF-36 will take up to 7 minutes to complete and will be assessed at each follow-up time point (time point 1 [T1] - time point 6 [T6]).	At each follow-up time point (1 month follow-up to 6-month follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization and work productivity	To assess the differences between groups in patient healthcare utilization will test the patient emergency department (ED) visits, hospital admissions (HA) admissions and feeding tube (FT) insertions. Will use a Chi-squared or Fisher's exact test, as appropriate, to compare the probability of healthcare services using a binary outcome (yes/no) between groups at a two-sided 0.025 significance level. Additional analyses will examine the number of times a patient visited the ED during the specified period. As a follow-up analysis, will examine group differences with logistic regression using randomization factors as model covariates (i.e., age, sex, ethnicity, stage, smoking status) as these factors may be associated with the study outcomes. Productivity loss will be measured by the Work Productivity and Activity Impairment General Health (WPAI-GH) assessing presence at the work place. Both patients and partners will complete items pertaining to productivity loss due to their health.	During radiation therapy (RT) and 90-days post-RT (T1-T5)
Physical and emotional intimacy	Sexual problems will be assessed with Majerovitz and Revenson's 6-item measure of sexual problems, which have successfully been used in our previous research in couples coping with cancer. Emotional intimacy will be measures with the validated and frequently used 6-item Personal Assessment of Intimacy in Relationships (PAIR) instrument, which has been validated in cancer. Will explore if the DY intervention improves physical and emotional intimacy following the procedures as described for the QOL (secondary) outcome. Will control for values of outcomes at baseline, as well as the randomization factors, in all the above analyses to improve power of the comparisons.	Baseline, end of treatment (T3), 3 months after RT (T5) and 6 months after RT (T6)
Treatment efficacy	Will examine if treatment efficacy on outcomes measured at 3MFU (T4) are achieved through improved symptoms and symptom management skills at the end of RT (T2) using linear regression analysis in both the intervention-mediator: (a) and intervention plus (+) mediator-outcome (b) paths. Ninety-five percent Bootstrap confidence intervals (CIs) will be constructed to assess the significance of the indirect (or mediation) effects defined using the product-of-coefficient approach. Will also use multilevel modeling (MLM) to test for interaction effects between intervention and the priori moderators, baseline depressive symptoms and dyadic adjustment. Significant interactions will be probed using simple slope analyses following the procedure developed for multilevel modeling by Preacher, Curran, and Bauer. These analyses will use a two-sided 0.05 significance level.	At the end of radiation therapy (T2)

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Neoplasms; Head and Neck Neoplasms; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: 2018-0887 (Other Identifier: M D Anderson Cancer Center); NCI-2020-02943 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No