Clinical trial NCT04607590: Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Official title: Yoga Program for Couples Coping With Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Carcinoma
Lung Carcinoma
Malignant Head and Neck Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)
timeFrame: At the 3-month follow-up
Secondary outcomes:
measure: Patient and partner short form survey (SF-36) domains
timeFrame: At each follow-up time point (1 month follow-up to 6-month follow-up)
Other outcomes:
measure: Healthcare utilization and work productivity
timeFrame: During radiation therapy (RT) and 90-days post-RT (T1-T5)
measure: Physical and emotional intimacy
timeFrame: Baseline, end of treatment (T3), 3 months after RT (T5) and 6 months after RT (T6)
measure: Treatment efficacy
timeFrame: At the end of radiation therapy (T2)
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathrin Milbury
role: PRINCIPAL_INVESTIGATOR
References: