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

Phase 1

Active, not recruiting

• Conditions: Any Cancer Type
• Interventions: Behavioral: EMI

• Registration Number: NCT06476548
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2024-06-12
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Primary Completion: 2024-08-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Completion: 2025-08-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usability Testing	EMI	Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app.

Primary Outcome Measures

Name	Time	Method
Utility of mindfulness practices	At 4 weeks	Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful).
Open-ended feedback	At 4 weeks	Participants' feedback will be collected using an open-ended question asking for feedback on the study app.
Likability of mindfulness practices	At 4 weeks	Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like).
Retention rate	At 4 weeks	We will assess the number of participants who complete the end-of-treatment survey.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States