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Clinical Trials/NCT06476548
NCT06476548CompletedPhase 1

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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country12 target enrollmentStarted: June 12, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Retention Rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Usability Testing

Experimental

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

Intervention: EMI (Device)

Outcomes

Primary Outcomes

Retention Rate

Time Frame: At 4 weeks

Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.

Likability of Mindfulness Practices

Time Frame: 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).

Utility of Mindfulness Practices

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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