RECRUITING

The Impact of a Race-Based Stress Reduction Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease. The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment. Participants will placed in one of the two following groups: * The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. * The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits: 1. Prior to starting the intervention 2. Mid-way through the intervention (Week 4) 3. End of the intervention (Week 8) 4. Six (6) months after the completion of the intervention

Official Title

The Impact of a Race-Based Stress Reduction Intervention on Well-Being, Inflammation, and DNA Methylation in African American Women At Risk for Cardiometabolic Disease

Quick Facts

Study Start:2023-10-18
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05902741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 50 and 75
  2. * Female
  3. * Post-menopausal (without menstrual period for at least 12 consecutive months)
  4. * Self-identified AA or Black
  5. * Able to write, read, speak English
  6. * Must have at least 1 of any of the following:
  7. * Waist circumference \>88 cm
  8. * Systolic BP\>130 mmHg and/ or diastolic BP\>88 mmHg or on antihypertensive medications
  9. * Diagnosed and/or being treated for hypercholesterolemia
  10. * History of Type 2 diabetes
  1. * History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
  2. * Any major immune-related disease (e.g., rheumatoid arthritis. lupus)
  3. * Use of immune-altering medications, such as glucocorticoids
  4. * Periodontal disease, bleeding gums, dental work in past 72 hours
  5. * Current smoker or has smoked in past 3 months
  6. * Active cancer
  7. * Active infection
  8. * Substance abuse
  9. * Cognitive or psychiatric disorder that would affect ability to participate in classes (Brief Screen for Cognitive Impairment total score of 8 or higher)

Contacts and Locations

Study Contact

Karen Saban, RN, PhD
CONTACT
708-216-1244
ksaban@luc.edu
Cara Joyce, PhD
CONTACT
708-216-300
cjoyce6@luc.edu

Principal Investigator

Karen Saban, RN, PhD
PRINCIPAL_INVESTIGATOR
Loyola University Chicago

Study Locations (Sites)

Loyola University Chicago
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Loyola University

  • Karen Saban, RN, PhD, PRINCIPAL_INVESTIGATOR, Loyola University Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Racism
  • Stress
  • Inflammation