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OpenTrials
Completed

NCT Number: NCT06476548

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

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.

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Key information

Conditions

Any Cancer Type Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMI

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.

Primary outcomes

  1. Retention Rate

    Time frame: At 4 weeks

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

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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