Digitally Enhanced Smoking Cessation for High Risk Smokers

Smoking Cessation Clinical Trial

Official title:

A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04691297
• Other study ID #: 20-457
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.

In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.

The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.

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Description:

• This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.

• This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:

• ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening

• Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks

• Participants will be in this research study for up to 6-months.

• It is expected that about 250 people will take part in this research study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: June 30, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

Inclusion Criteria:

• 55 to 77 years of age

• No previous history of lung cancer

• ECOG performance status < 2

• = 30 pack year smoking history

• Smoke = 5 cigarettes/day

• Own a mobile phone with access to a video call application

• Has a primary care provider (PCP)

• Provide contact information for the PCP

• Active health insurance

• Has not had LDCT screening

• English speaking

• Can complete an interview

Exclusion Criteria:

• Hospitalization for severe mental illness within the last year.

• The following special populations will not be included

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Lung Cancer Screening
• Lung Neoplasms
• Smoking
• Smoking Behaviors
• Smoking Cessation
• Smoking, Tobacco

Intervention

Other:
• Escape
The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.
• Standard Care
Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Association for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence smoking cessation rate	biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,	3 months
Primary	7-day point prevalence smoking cessation rate	biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,	6 months
Primary	number of cigarettes smoked/day	self-report number of cigarettes will be compared with exact Poisson test.	3 months
Primary	number of cigarettes smoked/day	self-report number of cigarettes will be compared with exact Poisson test.	6 months
Primary	Lung cancer screening behavior measure	(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,	3 Months
Primary	Lung cancer screening behavior measure	(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,	6 months
Secondary	Completion rate	The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) > 80% receipt and completion rate of watching the SNC digitalized videos.; Descriptive statistics (estimate and 95% CI) will be used to report completion rate.	1 month
Secondary	Completion rate	The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) > 80% receipt and completion rate of watching the SNC digitalized videos.; Descriptive statistics (estimate and 95% CI) will be used to report completion rate.	3 months
Secondary	Percentage of the group perceive the film as just right in length	defined as > 80% of the group perceive the film as just right in length in addition to favorable comments, the Narrative Engagement Scale scores are = to the established means ). Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.	1 month
Secondary	Percentage of the group indicate that the film would have value to others	> 80% of the group comments indicate that the film would have value to others and the Narrative Engagement Scale scores are = to the established means. Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.	3 months
Secondary	Narrative Engagement Scale scores	The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months [37] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with 7 indicating greater engagement.	1 month
Secondary	Narrative Engagement Scale scores	The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months [37] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with higher scores indicating greater engagement.	3 months
Secondary	Polygenic risk score (PRS)	We will construct three PRS. The first will be based on the lead single nucleotide polymorphisms (SNPs) from 183 independent genetic loci associated at genome-wide significance (p<5x10-8) with ever smoking status in adults from the UK Biobank and the Tobacco and Alcohol Genetic Consortium. The risk will be calculated as the weighted sum of each genetic variant, under an additive genetic model, counting the number of copies of the risk increasing allele. The weights will be proportional to the estimated effect size of each SNP. The second risk score will be constructed from a larger set of SNPs (~1 million) from the same GWAS using LDPred that allows for the construction of more powerful PRSs for specific racial groups using linkage disequilibrium information from large genetic reference panels. Finally, we will also construct a PRS based on the GWAS results for the largest available study specifically for nicotine dependence using the LDPred approach.	6 months
Secondary	Qualitative interviews	A semi-structured interview will be conducted with participants. Topics for the interview guide include; 1) perceptions of genomic evaluation, 2) experiences for providing risk information, 3) preferences for receiving risk information, 4) experiences with the study interventions, 5) suggestions for program improvements.	6 months