Cancer Clinical Trial - SMLI With Hispanic Cancer Survivors & Caregivers

Status Recruiting

Clinical Trial Summary

Fewer than 20% of Hispanic cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Diagnosed at younger ages, later stages and with fewer resources (e.g., access to care), Hispanic cancer survivors are more likely to suffer from many symptoms, which linger long after they have completed treatment and may prevent them from leading a healthy life. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This randomized controlled trial tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health.

Clinical Trial Description

In the proposed randomized controlled trial, the investigators will test the 12-week SMLI against an attention control condition in 107 dyads of Hispanic cancer survivors who have completed curative treatments within the past two years and their informal caregivers. A 12-week follow-up will determine the sustainability of the intervention. The primary outcome of this trial, vegetable and fruit intake in survivors (secondary in caregivers), will be measured at baseline, 13, and 25 weeks, using validated methods. Additional secondary and exploratory outcomes will add to the rigor of the trial and provide robust findings for future dissemination efforts. Specific Aim #1: Test the efficacy of the SMLI as compared to attention control among Hispanic female cancer survivors and their caregivers with respect to: 1. Increase in fruit and vegetable consumption (measured via self-reported 24-hour recall and objectively with carotenoid skin colorimetry) 2. Increase in physical activity (Metabolic Equivalents hours/week of moderate to vigorous physical activity measured by actigraphy) and decrease in symptom severity index Specific Aim #2: Determine the extent to which improvements in primary and secondary outcomes over weeks 13 and 25 are mediated by social support and self-efficacy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05364372
Study type	Interventional
Source	University of Arizona
Contact	Samantha Werts, MPH
Phone	520-626-8712
Email	swerts@arizona.edu
Status	Recruiting
Phase	N/A
Start date	August 25, 2022
Completion date	March 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SMLI With Hispanic Cancer Survivors and Caregivers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms