Mindfulness App for Smoking Cessation in Cancer Survivors

Overseen By Min-Jeong Yang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Smoking cessation medications

Disqualifiers: Psychosis, Pregnancy, Lactation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment EMI for smoking cessation in cancer survivors?

Research shows that mindfulness-based programs can help cancer survivors improve their psychological well-being and quality of life, which might indirectly support smoking cessation efforts. Additionally, mindfulness-based stress reduction has been effective in improving sleep and reducing distress in cancer survivors, suggesting potential benefits for overall health and lifestyle changes. ^{1 2 3 4 5}

Is the mindfulness app for smoking cessation safe for cancer survivors?

The research on mindfulness apps for smoking cessation in cancer survivors suggests they are generally safe, as they focus on reducing stress and cravings without any reported harmful effects. ^{6 7 8 9 10}

How is the mindfulness app treatment for smoking cessation in cancer survivors different from other treatments?

The mindfulness app for smoking cessation is unique because it combines mindfulness training, which helps reduce stress and cravings, with the convenience of a smartphone app, making it accessible to young cancer survivors who are geographically dispersed and may struggle with depression. ^{6 7 8 9 11}

What is the purpose of this trial?

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.

Research Team

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Min-Jeong Yang, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

I am willing to attempt quitting as part of the study.

Having a smartphone that allows installation of the app

Exclusion Criteria

Evidence of current psychosis

I am currently using medication to help me stop smoking.

Being enrolled in a smoking cessation program

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Usability Testing Experimental Treatment 1 Intervention

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

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. Lopez, G., Chaoul, A., Warneke, CL., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized wait-list controlled trial of feasibility and efficacy of an online mindfulness-based cancer recovery program: the eTherapy for cancer applying mindfulness trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Intra-individual study of mindfulness: ecological momentary perspective in post-surgical lung cancer patients. [2020]

5. Scotland pubmed.ncbi.nlm.nih.gov

The mindfulness-based stress reduction program for improving sleep quality in cancer survivors: A systematic review and meta-analysis. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Reach versus effectiveness: The design and protocol of randomized clinical trial testing a smartphone application versus in-person mindfulness-based smoking cessation intervention among young cancer survivors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effect of a mindfulness training app on a cigarette quit attempt: an investigator-blinded, 58-county randomized controlled trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation. [2021]