Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

This mHealth automated treatment (AT) approach includes a fully automated, interactive, personalized, smartphone-based intervention for behavioral treatment, delivered through their Insight platform.

It had two arms (groups): Automated Treatment (experimental) and Standard Care (active comparator).

AT consists of all SC components plus a fully automated smartphone-based JITAI that involves proactive, interactive, and personalized messages, images, or videos in Lao.

The registry classes the interventions as behavioral and drug.

More on the Plan

These iterative steps include modifying content, user testing and eliciting feedback, and refining.

The investigators will ensure that approximately half of these testing users are women and that the whole testing sample is demographically diverse.

Using input and feedback from these testing users, the investigators will revise the AT further if needed.

These series of tests and user-feedback sessions to refine the content further and to debug the system will go through an iterative process as needed.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged ≥18 years. Self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day). Willing to set a quit date within 2 weeks of study enrollment. Able to provide written informed consent to participate. Able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: history of a medical condition that precludes use of nrt; ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician; enrollment in another cessation program or current use of other cessation medications.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-04-20 with completion listed for 2023-08-31.

It ran at 2 sites in Laos (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months (time frame: 3 months post enrollment (window for the 3-month follow-up assessment: weeks 10-14)).

It also tracked 4 secondary outcomes, for example Cigarettes Smoked Per Day at 3-month Follow-up (Quit=0) Among All Participants and Cigarettes Smoked Per Day at 3-month Follow-up Among Participants Who Smoked at 3 Months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 80 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.