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Clinical Trials/NCT05087875
NCT05087875
Completed
Not Applicable

Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors

Carolyn Lauckner1 site in 1 country40 target enrollmentNovember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Carolyn Lauckner
Enrollment
40
Locations
1
Primary Endpoint
Percent of Eligible Participants Enrolling in the Study
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among adolescent and young adult (AYA) cancer survivors during post-treatment survivorship.

At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention.

Detailed Description

For this study, the investigators will adapt and pilot an existing mHealth intervention (TRAC) to reduce alcohol use among AYAs as part of a randomized controlled trial. TRAC includes weekly phone sessions with an interventionist and incorporates smartphones for daily self-monitoring of alcohol use. Upon enrollment, participants will be randomized into either the intervention (TRAC) arm or control (education and daily self-monitoring) arm. Researchers will conduct the study in Kentucky, which leads the nation in cancer incidence and mortality, has a higher incidence of AYA cancers compared to other states, is 40% rural, and encompasses over 100 medically underserved areas. Participants will be recruited from the University of Kentucky Markey Cancer Center and its affiliate institutions. Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.

Registry
clinicaltrials.gov
Start Date
November 28, 2022
End Date
July 25, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Carolyn Lauckner
Responsible Party
Sponsor Investigator
Principal Investigator

Carolyn Lauckner

Associate Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with cancer between age 15-39
  • Currently age 18-39
  • 3 months-15 years post-treatment
  • Meets criteria for risky alcohol use
  • Reside in United States

Exclusion Criteria

  • Severe psychopathology

Outcomes

Primary Outcomes

Percent of Eligible Participants Enrolling in the Study

Time Frame: 17 months

The primary feasibility outcome is enrollment, with a goal of 60% of eligible AYAs approached enrolling in the study. A higher percentage of individuals who enroll in the study indicate the intervention is accessible to the target population.

Secondary Outcomes

  • Percent of Participants Completing Follow-up(10 weeks)
  • Percent of Participants Completing Majority of Intervention Sessions(6 weeks)
  • Average Percent of Daily Monitoring Tasks Completed(6 weeks)

Study Sites (1)

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