Viewing Study NCT05364372



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Last Modification Date: 2024-10-26 @ 2:32 PM
Study NCT ID: NCT05364372
Status: RECRUITING
Last Update Posted: 2023-12-13
First Post: 2022-04-29

Brief Title: SMLI With Hispanic Cancer Survivors and Caregivers
Sponsor: University of Arizona
Organization: University of Arizona

Study Overview

Official Title: Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Fewer than 20 of Hispanic cancer survivors meet the American Cancer Societys ACS Guidelines on Nutrition and Physical Activity Diagnosed at younger ages later stages and with fewer resources eg 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
Detailed 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 hoursweek 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None