Evaluating an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors

NCT05087875 | Completed Results DMC

• 2 other identifiers: 67410R21CA261844
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Alcohol Use

Outcome Measures

Primary Outcomes (1)

• Percent of Eligible Participants Enrolling in the Study

  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.

  17 months

Secondary Outcomes (3)

• 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

Other Outcomes (10)

• Daily Drinking

  Daily for 6 weeks

• Blood Alcohol Content

  Daily for 6 weeks

• Alcohol Use

  Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)

Study Arms (2)

TRAC: Tracking and Reducing Alcohol Consumption

EXPERIMENTAL

The TRAC intervention focuses on increasing motivation and building skills to reduce alcohol use and involves 4, 30-minute sessions with an interventionist done via video chat or phone. Participants will complete smartphone-based self-monitoring of alcohol use. Each morning, participants complete a mobile survey indicating if they drank the previous day and if so, how many drinks they had. Surveys will be programmed using REDcap and sent via a link in the reminder text message. Additionally, participants will be prompted each evening and asked to complete a breathalyzer reading using a mobile app to determine blood alcohol content (BAC). If safety concerns are identified (e.g., BAC ≥0.30; blackouts), the interventionist will refer the AYA to a licensed provider with expertise in substance use treatment.

Behavioral: TRAC: Tracking and Reducing Alcohol Consumption

Control

ACTIVE COMPARATOR

Participants in the control group will receive educational materials regarding alcohol consumption and its link to cancer . They will also participate in smartphone monitoring of alcohol use on the same schedule as participants in the intervention group. This will allow us to compare daily alcohol use data between the two conditions and evaluate the added component of weekly counseling in TRAC.

Other: No intervention

Interventions

TRAC: Tracking and Reducing Alcohol Consumption BEHAVIORAL

The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. Participants set goals for reducing their drinking and learn strategies to help them achieve those goals. It requires four 30-minute sessions with a counselor using mobile phones.

TRAC: Tracking and Reducing Alcohol Consumption

No intervention OTHER

The comparison group will be evaluated based on daily self-monitoring data.

Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Severe psychopathology

Sponsors & Collaborators

• Carolyn Lauckner: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Neoplasms; Alcohol Drinking

Interventions

Ethanol; Economics

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Health Care Economics and Organizations

Results Point of Contact

• Title: Carolyn Lauckner
• Organization: University of Kentucky

carolyn.lauckner@uky.edu

8595623335

Study Officials

• Carolyn Lauckner, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: November 28, 2022
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)