NCT06476548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 15, 2025

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

June 21, 2024

Results QC Date

June 26, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

Smoking CessationCancer Survivor

Outcome Measures

Primary Outcomes (3)

  • Retention Rate

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

    At 4 weeks

  • Likability of Mindfulness Practices

    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).

    At 4 weeks

  • Utility of Mindfulness Practices

    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).

    At 4 weeks

Study Arms (1)

Usability Testing

EXPERIMENTAL

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

Device: EMI

Interventions

EMIDEVICE

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.

Usability Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Yang MJ, Sutton SK, Cottrell-Daniels C, Ritterband LM, Blackwell R, Maconi ML, Poudel R, Pabbathi S, Simmons VN, Vinci C. Mindfulness-based ecological momentary intervention for smoking cessation to address cancer-related relapse risk factors: Intervention development and usability findings. Mindfulness (N Y). 2026 Mar 9:10.1007/s12671-026-02775-0. doi: 10.1007/s12671-026-02775-0. Online ahead of print.

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Dr. Christine Vinci
Organization
Moffitt Cancer Center

Study Officials

  • Christine Vinci, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR
  • Min-Jeong Yang, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 26, 2024

Study Start

June 12, 2024

Primary Completion

August 26, 2024

Study Completion

August 26, 2024

Last Updated

April 2, 2026

Results First Posted

July 15, 2025

Record last verified: 2026-03

Locations