Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04607590
Other study ID # 2018-0887
Secondary ID NCI-2020-0294320
Status Active, not recruiting
Phase
First received
Last updated
Start date May 31, 2019
Est. completion date April 30, 2025

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Best Practice
Receive usual care
Procedure:
Quality-of-Life Assessment
Ancillary studies
Other:
Questionnaire Administration
Ancillary studies
Procedure:
Yoga
Participate in yoga sessions

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other 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)
Other 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)
Primary 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 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)
See also
  Status Clinical Trial Phase
Recruiting NCT06030427 - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT05660421 - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors Phase 2
Suspended NCT04060849 - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY Phase 1
Recruiting NCT06192875 - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed NCT04122118 - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor N/A
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT03168737 - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients Phase 1
Active, not recruiting NCT06062901 - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors N/A
Active, not recruiting NCT02444741 - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT04081298 - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors N/A
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Completed NCT04983901 - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN Phase 2
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Recruiting NCT04871542 - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting NCT04592250 - Financial Toxicity in Cancer Patients
Recruiting NCT05112614 - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting NCT04296305 - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain Phase 4
Recruiting NCT05873608 - Communication Issues in Patient and Provider Discussions of Immunotherapy N/A
Recruiting NCT02464696 - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure N/A