Clinical trial NCT05087875: Evaluating an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors
Official title: Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Alcohol Use
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Enrollment
timeFrame: 17 months
Secondary outcomes:
measure: Retention
timeFrame: 10 weeks
measure: Intervention adherence
timeFrame: 10 weeks
Other outcomes:
measure: Daily drinking
timeFrame: Daily for 6 weeks
measure: Blood alcohol content
timeFrame: Daily for 6 weeks
measure: Alcohol use
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Overall Health
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Self-efficacy
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Personal control over alcohol use
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Alcohol negative consequences
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Alcohol positive consequences
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Tobacco use
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
measure: Emotional support
timeFrame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Carolyn Lauckner, PhD
role: PRINCIPAL_INVESTIGATOR
References: