Mindfulness App for Smoking Cessation in Cancer Survivors

MY
Overseen ByMin-Jeong Yang, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help cancer survivors quit smoking. It gathers feedback on the app's effectiveness and user-friendliness when combined with brief counseling and nicotine replacement therapy. Individuals who have smoked recently, have a cancer diagnosis, and are willing to try quitting with the app are suitable candidates. Participants need a smartphone to use the app daily and should not currently participate in any smoking cessation programs or use related medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial requires that you are not currently using smoking cessation medications, so you would need to stop those if you are taking them.

What prior data suggests that this app is safe for cancer survivors?

Research has shown that digital programs to help people quit smoking, like the one being tested, can be beneficial, even if the effects are sometimes small. These programs use tools like smartphone apps to assist cancer survivors in quitting smoking.

While detailed safety information on this specific app is not yet available, similar digital programs are generally safe. They are considered low-risk because they don't involve medications or medical procedures.

Participants in similar studies have reported few side effects, mostly related to the usual challenges of quitting smoking, such as cravings and mood swings. Since this trial is in an early stage, it primarily focuses on gathering user feedback and assessing the app's usability. Detailed safety information is still being collected, but the emphasis on usability suggests that the app is expected to be safe.12345

Why are researchers excited about this trial?

Unlike traditional smoking cessation treatments like nicotine replacement therapies, medications such as varenicline or bupropion, and behavioral counseling, the mindfulness app for smoking cessation in cancer survivors offers a novel approach by integrating technology with psychological support. This app-based intervention makes it convenient and accessible, allowing users to engage with the program at their own pace and in their own environment. Researchers are excited because it combines brief counseling and nicotine replacement therapy with mindfulness techniques, delivered directly through a smartphone app, potentially enhancing adherence and effectiveness by providing support whenever needed. This innovative approach aims to address both the physical and psychological aspects of quitting smoking, which could be especially beneficial for cancer survivors dealing with unique stressors.

What evidence suggests that this mindfulness app is effective for smoking cessation in cancer survivors?

Research has shown that smartphone apps can help people quit smoking. Specifically, apps offering personalized support at critical moments can increase the chances of quitting. One study found that users of the Smart-T app were more successful at quitting than those using a standard guide, with 37% not smoking for at least seven days. Additionally, digital tools designed for cancer survivors have reduced the number of cigarettes smoked weekly. These findings suggest that the mindfulness app tested in this trial could effectively help cancer survivors quit smoking by providing timely support and motivation.12678

Who Is on the Research Team?

MY

Min-Jeong Yang, PhD

Principal Investigator

Moffitt Cancer Center

CV

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer survivors who smoke and are willing to try quitting. Participants must be able to use an app on their smartphone daily, speak English, and have smoked recently. They can't join if they're using other quit-smoking treatments, are pregnant or breastfeeding, or have current psychosis.

Inclusion Criteria

I am willing to download and use the app every day.
Having a smartphone that allows installation of the app
I am willing to attempt quitting as part of the study.
See 3 more

Exclusion Criteria

Evidence of current psychosis
I am currently using medication to help me stop smoking.
Being enrolled in a smoking cessation program
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brief cessation counseling, nicotine replacement therapy, and intervention content via the app

4 weeks
Face-to-face counseling and app-based intervention

Follow-up

Participants are monitored for feedback and retention after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EMI
Trial Overview The study tests a new quit-smoking treatment delivered through a prototype app designed for individuals with a cancer diagnosis. It aims to gather user feedback on the effectiveness of this mindfulness-based intervention.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Usability TestingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A randomized controlled trial is being conducted with 422 cancer patients to test the efficacy of a smartphone app called Quit2Heal, which is designed to help cancer patients quit smoking by addressing issues like shame, stigma, and anxiety related to their condition.
Quit2Heal is based on Acceptance and Commitment Therapy and aims to achieve higher smoking cessation rates compared to a standard app (QuitGuide) by focusing on the unique psychological challenges faced by cancer patients, potentially leading to better cancer treatment outcomes.
Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial.Bricker, JB., Westmaas, JL., Ostroff, JS., et al.[2023]
A pilot study involving 35 cancer patients showed that a smartphone-based meditation app is feasible and acceptable, with a 61% enrollment rate and 71% adherence over two weeks.
Participants using the app reported significant improvements in anxiety, fatigue, and overall distress, particularly with longer meditation sessions (15 minutes), suggesting the app could be a beneficial tool for managing mood symptoms in cancer patients.
Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study.Lopez, G., Chaoul, A., Warneke, CL., et al.[2023]
The individualized mindfulness-based stress reduction (IMBSR) program was feasible and acceptable for 19 head and neck cancer patients undergoing treatment, suggesting it can be integrated into their care.
Higher levels of post-intervention mindfulness were linked to lower psychological distress and improved quality of life, indicating that mindfulness practices may benefit patients during active cancer treatment.
Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study.Pollard, A., Burchell, JL., Castle, D., et al.[2022]

Citations

An Ecological Momentary Intervention for Smoking CessationUsing smartphones to detect high relapse risk situations and automatically deliver tailored smoking cessation interventions may help ...
Study Details | NCT07210567 | Mindfulness-based ...The purpose of the study is to develop a new quit-smoking treatment among individuals with a cancer diagnosis using a smartphone app. Detailed ...
Impact of Ecological Momentary Assessment Participation ...This study attempted to isolate and examine the effect of incentivizing EMA engagement on smoking cessation success for adults using a smartphone app to quit.
Quit Rate Higher With Smart-T vs NCI QuitGuideOverall, the researchers found that the Smart-T group had an increased abstinence rate for 7-day PPA compared with the QuitGuide group (37 ...
Digital Smoking Cessation Intervention for Cancer SurvivorsThe number of cigarettes smoked in the past 7 days at 6-month follow-up was the primary outcome measure. We analyzed interactions among ...
Digital Smoking Cessation Intervention for Cancer SurvivorsRecent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors. However ...
Financial Incentives for Smoking Cessation Among ...This randomized clinical trial of 320 participants compared usual care (counseling and pharmacotherapy) with usual care plus modest financial incentives.
Mindfulness-Based Ecological Momentary Intervention For ...Trial Title: Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors. NCT ID: NCT06476548.
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