University of Kentucky
Lexington, Kentucky, 40506, United States
NCT Number: NCT05087875
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.
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Notify Me18 year–39 year
All sexes
Interventional
Not applicable
Lexington, Kentucky, 40506, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The comparison group will be evaluated based on daily self-monitoring data.
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.
Time frame: 10 weeks
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.
Time frame: 6 weeks
One of the secondary feasibility outcomes is intervention adherence, with a goal of 70% of participants completing the majority (3/4 or 75%) of intervention sessions. Higher percentages indicate a greater degree of acceptability of the intervention. This outcome was only measured among the intervention group.
Time frame: 6 weeks
Monitoring adherence is measured by the average percentage of daily surveys and breathalyzers completed by participants.
Time frame: Daily for 6 weeks
This outcome will be measured using participants' self-reported alcohol use on a 4-item survey. This will assess whether any alcohol was consumed, the number of drinks, time since last drink, and plans to drink later in the day. Higher reports of daily drinking indicate greater consumption of alcohol.
Time frame: Daily for 6 weeks
This will be measured using the BACTrack Mobile Pro breathalyzer, with results being sent to the study team via mobile app. Higher blood alcohol content indicates greater consumption of alcohol.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
This will be measured using the PROMIS SF Alcohol 7a, which is a 7-item questionnaire used to assess alcohol use over the past 30 days.
Raw scores can range from 7-35. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates more alcohol use in the past 30 days.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
This will be measured using the PROMIS-29 plus 2 v2.1, a 31 item scale which provides an overall profile of health with sub-scales (i.e., physical function, depression, anxiety, ability to participate in social roles/activities, sleep disturbance, fatigue, pain interference, pain intensity).
All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates more of the concept being measured, which scores calculated separately for each of the subscales.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
Self-efficacy will be measured using the PROMIS Self-efficacy SF 4a, a 4-item assessment of overall confidence in one's ability to solve problems and cope.
Scores can range from 4-16. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates higher self-efficacy.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
This outcome will be measured using the Personal Control Scale, which consists of 15 items and assesses personal control over drinking in the past 90 days (at baseline; past 60 days for post-intervention), and perceived control over one's current drinking. Scores can range from 0-60. Higher scores on this scale indicate participants' perceiving to have a greater degree of personal control over their drinking.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
This outcome will be measured using the PROMIS SF Alcohol Use-Negative Consequences 7a, which is a 7-item scale that assesses perceived negative consequences of using alcohol in the past 30 days (e.g. unreliable, social problems, judgement).
Raw scores can range from 7-45. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of perception of negative consequences surrounding alcohol use in the past 30 days.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
The PROMIS adult Alcohol Use - Positive Consequences item bank assesses positive personal outcomes of alcohol use over the past 30 days. These items cover physical (e.g., improved sleep, increased sexual desire), mental (e.g., happiness, creativity, positive self-image), and social (e.g., comfort around others, ease in talking to others) consequences of drinking.
Raw scores can range from 7-45. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of perception of positive consequences surrounding alcohol use in the past 30 days.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
This outcome will be measured using the Cancer Patient Tobacco Use Questionnaire (core items), which is a 4-item survey that assesses participants' lifetime and current tobacco use. This questionnaire is not scored.
Time frame: Measured at baseline, post-intervention (6 weeks), and one month post-intervention (10 weeks)
Social support will be measured using the PROMIS Emotional Instrumental Support V2. This consists of 12 items, and assesses perceived emotional support and instrumental support (e.g. help with tasks).
Raw scores can range from 12-60. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of emotional support.
Carolyn Lauckner
Other
Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors
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