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

NCT ID: NCT05087875

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2024-07-25

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.

Conditions

Cancer; Alcohol Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRAC: Tracking and Reducing Alcohol Consumption

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.

Group Type: EXPERIMENTAL

TRAC: Tracking and Reducing Alcohol Consumption

Intervention Type: 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

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

Interventions

TRAC: Tracking and Reducing Alcohol Consumption

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.

Intervention Type: BEHAVIORAL

No intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Carolyn Lauckner

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Lauckner

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carolyn Lauckner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R21CA261844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

67410

Identifier Type: -

Identifier Source: org_study_id