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

Active, not recruiting

• Conditions: Malignant Head and Neck Neoplasm; Malignant Solid Neoplasm; Esophageal Carcinoma; Lung Carcinoma
• Interventions: Procedure: Quality-of-Life Assessment; Other: Best Practice; Other: Questionnaire Administration; Procedure: Yoga

• Registration Number: NCT04607590
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2019-05-31
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I (DY)	Quality-of-Life Assessment	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 III (WLC)	Questionnaire Administration	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.
Group I (DY)	Yoga	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 I (DY)	Questionnaire Administration	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)	Quality-of-Life Assessment	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.
Group III (WLC)	Quality-of-Life Assessment	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.
Group II (PY)	Yoga	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.
Group II (PY)	Questionnaire Administration	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.
Group III (WLC)	Best Practice	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.
Group III (WLC)	Yoga	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.

Primary Outcome Measures

Name	Time	Method
The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)	At the 3-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Patient and partner short form survey (SF-36) domains	At each follow-up time point (1 month follow-up to 6-month follow-up)	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 \[T6\]).

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States