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

Study Overview
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Brief Summary
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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 rural 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
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For this study, the investigators will adapt and pilot an existing mHealth intervention (TRAC) to reduce alcohol use among rural 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.

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

Conditions
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Cancer, Alcohol Use

Intervention / Treatment
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* Behavioral: TRAC: Tracking and Reducing Alcohol Consumption
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cancer between age 15-39 1-10 years post-treatment Primary rural residence Meets criteria for risky alcohol use Exclusion Criteria: Severe psychopathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRAC: Tracking and Reducing Alcohol Consumption<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* The comparison group will be evaluated based on daily self-monitoring data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | One of the secondary feasibility outcomes is retention, with a goal of 60% of study participants completing follow-up. A higher percentage of individuals completing follow-up indicates a greater degree of acceptability of the intervention. | 12 weeks | 
| Intervention adherence | One of the secondary feasibility outcomes is intervention adherence, with a goal of 70% of participants completing the program and attending 75% of intervention sessions; with 70% completing the alcohol monitoring. Higher percentages across each of these indicate a greater degree of acceptability of the intervention. | 12 weeks |