Smartphone-delivered automated treatment for Smoking, Cessation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
Smoking, Cessation
Smartphone-delivered automated treatment - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a smartphone-based smoking cessation intervention is effective and cost-effective.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Smartphone-delivered automated treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Smoking, Cessation. Measurement will happen over the course of 12 Month Follow-Up.

12 Month Follow-Up
30 Day Smoking Abstinence
Continuous Smoking Abstinence
Self Reported 24 Hours Smoking Abstinence
Self Reported 7 Day Abstinence Smoking Status
Smoking Status by Saliva Cotinine Kit

Trial Safety

Trial Design

2 Treatment Groups

Standard Treatment
1 of 2
Automated Treatment
1 of 2
Active Control
Experimental Treatment

This trial requires 500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Smartphone-delivered Automated Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Automated TreatmentParticipants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Standard TreatmentParticipants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-delivered automated treatment
2017
Completed Phase 4
~40
Nicotine
FDA approved
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 month follow-up for reporting.

Closest Location

Moffitt Cancer Center - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
>100 lifetime cigarettes
English or Spanish speaking
You are currently smoking.\n show original
Willing to make a quit attempt within 1 week of enrollment
Process a smartphone compatible with the project app
You have a valid email address. show original

Patient Q&A Section

What are common treatments for smoking, cessation?

"There are a variety of treatment options for smoking, including medication and treatment by practitioner. All the options can be effective for smoking, cessation and prolonging long-term abstinence. There is growing evidence that telephone counselling is as effective as face-to-face counselling in smoking, cessation and maintenance. As well as assisting with smoking cessation, smoking cessation support should include encouragement to decrease alcohol intake and reduce other unhealthy behaviour." - Anonymous Online Contributor

Unverified Answer

How many people get smoking, cessation a year in the United States?

"There are approximately 1.3 million people who were smokers in the United States in 2013. About 18-41% of those who reported engaging in regular smoking in previous year were in an attempt to quit, which is similar to estimates from previous years. However, progress towards achieving cigarette-free status was minimal: only about 3.6% of smokers thought that they were not smoking at all, compared with 4.5% in 2012. To a large extent, such changes must be attributed to the fact that the majority of U.S. adults remain at risk of developing chronic tobacco-related conditions (e.g., cancer)." - Anonymous Online Contributor

Unverified Answer

What is smoking, cessation?

"Health behaviour in adults is linked to many factors and depends largely on personal determinants (e.g. gender, socio-economic status) and contextual characteristics (e.g. environment, social policy context). Smoking cessation is a behaviour that has the potential to improve the health of many populations. It would therefore be beneficial to understand the factors predictive of [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) and to devise effective strategies for smoking cessation. Clearly, individual factors are paramount, but these may involve, in addition to personal determinants, broader socio-cultural, socio-economic, behavioural, behavioural environmental and policy contexts, in order to understand smoking behaviour and provide health services." - Anonymous Online Contributor

Unverified Answer

What are the signs of smoking, cessation?

"For example: it is necessary to exclude and screen patients for signs of depression, anxiety, psychosis, personality disorders (psychopaths), alcoholism, addiction to illegal drugs or cannabis." - Anonymous Online Contributor

Unverified Answer

Can smoking, cessation be cured?

"With proper treatment in a [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) program, most smokers can be made not to smoke again. However, even after smoking cessation, the chances of relapse are still small. Furthermore, most smokers still find that smoking is essential to their quality of life." - Anonymous Online Contributor

Unverified Answer

What causes smoking, cessation?

"Cessation of smoking is more difficult if people have low perceived control or self-efficacy, because smoking causes nicotine dependence and it may also lead to low perceived control." - Anonymous Online Contributor

Unverified Answer

How does smartphone-delivered automated treatment work?

"The automated treatments reported in this paper provide an alternative to current treatment in terms of reducing distress, perceived stigma, craving and smoking. This method is easy to implement with minimal supervision, inexpensive and portable. Data from a recent study support the possibility of mobile intervention approaches being effective for smoking-related problems. Moreover, the findings suggest that people at elevated risk of relapse may benefit from these methods." - Anonymous Online Contributor

Unverified Answer

What is smartphone-delivered automated treatment?

"[A recent study(http://www.toxonline.com/tox/tox-item/show/133529/) found that smartphone-delivered automated treatment had a clinical meaningful improvement in reducing of tics, not smoking, and alcohol use after 12 to 30 months]" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving smartphone-delivered automated treatment?

"Recent findings is the first to evaluate the feasibility, efficacy, and usability of a smartphone-delivered ATS. This is particularly important given the increasing number of patients receiving adjuvant therapy. Additional studies are needed to explore treatment efficacy in a larger clinical trial and to quantify the cost-effectiveness of smartphone-delivered ATS in the outpatient treatment for head and neck cancer." - Anonymous Online Contributor

Unverified Answer

How serious can smoking, cessation be?

"Most patients were informed that [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) has the potential to have adverse health effects (i.e. stroke, lung cancer, heart attack, emphysema, chronic bronchitis, and gastrointestinal problems). In addition, patients did not find any significant benefit from being informed on smoking cessation. Patient motivation has an important role to play in informing patients, encouraging them to quit smoking and, with the support of health professionals, assisting them. The potential adverse effects of smoking cessation and the health benefits of smoking cessation can be presented together using the transtheoretical model." - Anonymous Online Contributor

Unverified Answer

Does smartphone-delivered automated treatment improve quality of life for those with smoking, cessation?

"Smokers who received treatment via smartphone showed improvements in perceived quality of life but did not achieve the same degree of improvement seen in the control group." - Anonymous Online Contributor

Unverified Answer

Has smartphone-delivered automated treatment proven to be more effective than a placebo?

"In addition to providing an important, low-cost method to support [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation), N Quit System is effective irrespective of individual factors such as age, gender, and smoking history." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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