Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors

NCT ID: NCT06476548

Last Updated: 2026-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2024-08-26

Brief Summary

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The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.

Detailed Description

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The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.

Conditions

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Any Cancer Type

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Usability Testing

Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app.

Group Type EXPERIMENTAL

EMI

Intervention Type DEVICE

Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches.

Interventions

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EMI

Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having smoked at least one cigarette (even one or two puffs) within the past 30 days.
* Having been diagnosed with cancer.
* Willing to give quitting a try as part of the study.
* Having a smartphone that allows installation of the app.
* Willingness to download and use the app daily.
* Valid home address and functioning phone number.
* Being able to read, write, and speak English.

Exclusion Criteria

* Being enrolled in a smoking cessation program.
* Current use of smoking cessation medications.
* Evidence of current psychosis.
* Current/planning pregnancy or lactation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Vinci, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Min-Jeong Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials Website

Other Identifiers

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K99CA271040

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-22266

Identifier Type: -

Identifier Source: org_study_id

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