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

Primary Purpose

Cancer, Alcohol Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRAC: Tracking and Reducing Alcohol Consumption
No intervention
Sponsored by
Carolyn Lauckner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRAC: Tracking and Reducing Alcohol Consumption

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 8, 2021
Last Updated
July 11, 2023
Sponsor
Carolyn Lauckner
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05087875
Brief Title
Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors
Official Title
Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carolyn Lauckner
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Alcohol Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRAC: Tracking and Reducing Alcohol Consumption
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRAC: Tracking and Reducing Alcohol Consumption
Intervention Description
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
Other
Intervention Name(s)
No intervention
Intervention Description
The comparison group will be evaluated based on daily self-monitoring data.
Primary Outcome Measure Information:
Title
Enrollment
Description
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
12 months
Secondary Outcome Measure Information:
Title
Retention
Description
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
12 weeks
Title
Intervention adherence
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Daily drinking
Description
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 4-8 weeks
Title
Blood alcohol content
Description
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
Daily for 4-8 weeks
Title
Alcohol use
Description
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 and post-intervention (4-8 weeks)
Title
Overall Health
Description
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 and post-intervention (4-8 weeks)
Title
Self-efficacy
Description
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 and post-intervention (4-8 weeks)
Title
Personal control over alcohol use
Description
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 and post-intervention (4-8 weeks)
Title
Alcohol negative consequences
Description
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 and post-intervention (4-8 weeks)
Title
Alcohol positive consequences
Description
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 and post-intervention (4-8 weeks)
Title
Tobacco use
Description
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
Title
Emotional support
Description
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.
Time Frame
Measured at baseline and post-intervention (4-8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Lauckner, PhD
Phone
859-562-3335
Email
carolyn.lauckner@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Lauckner, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Lauckner, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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