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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Esophageal Carcinoma; Malignant Head and Neck Neoplasm; Lung Carcinoma; Malignant Solid Neoplasm

Treatments: Procedure: Quality-of-Life Assessment; Procedure: Yoga; Other: Best Practice; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04607590

2018-0887 (Other Identifier)

NCI-2020-02943 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Group I (DY)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Yoga

Procedure: Quality-of-Life Assessment

Group II (PY)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Yoga

Procedure: Quality-of-Life Assessment

Group III (WLC)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Procedure: Yoga

Procedure: Quality-of-Life Assessment