Quit2Heal App for Smoking Cessation in Cancer Patients

Recruiting at 1 trial location

Overseen By Jonathan B Bricker

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Other smoking cessation, Prior trials, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

427 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to the QuitGuide app in helping cancer patients quit smoking. Both apps provide tools to cope with urges to smoke, step-by-step guides for quitting smoking, help in planning for quitting and staying tobacco-free, and scientifically-based recommendations for how to select medications that aid in smoking cessation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on smoking cessation and the use of specific apps.

What data supports the effectiveness of the Quit2Heal App treatment for smoking cessation in cancer patients?

The Quit2Heal App is designed specifically for cancer patients and is based on Acceptance and Commitment Therapy, which helps people accept cravings without smoking and stay motivated to quit. A study is testing its effectiveness compared to another app, QuitGuide, to see if it helps more cancer patients quit smoking over 12 months. ^{1 2 3 4 5}

Is the Quit2Heal app safe for use in humans?

The available research does not provide specific safety data for the Quit2Heal app, but it is designed as a behavioral therapy tool, which generally poses minimal risk to users. ^{1 3 4 6 7}

How is the Quit2Heal app treatment different from other smoking cessation treatments for cancer patients?

The Quit2Heal app is unique because it is specifically designed for cancer patients, addressing issues like cancer-related shame, stigma, depression, and anxiety, while using Acceptance and Commitment Therapy to help users accept cravings without smoking and stay motivated to quit. This app is tailored to the needs of cancer patients, unlike general smoking cessation apps, and aims to be a more effective and accessible option integrated with oncology care. ^{1 3 4 8 9}

Research Team

Jonathan B Bricker

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for adults over 18 in the US who have been diagnosed with cancer within the last two years or are undergoing treatment. Participants must be current smokers interested in quitting, willing to use a smartphone app for cessation, and able to complete surveys. They should not be using other quit-smoking programs or have used NCI's QuitGuide app.

Inclusion Criteria

Providing email, phone number(s), and mailing address

Not currently (i.e., within past 30 days) using other smoking cessation interventions

Have never participated in our prior research trials

Exclusion Criteria

Has used the NCI's QuitGuide app

Not providing email, phone number(s), and mailing address

I have used other methods to quit smoking in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Quit2Heal app or the QuitGuide app and are encouraged to use it frequently

12 months

App usage is encouraged throughout the period

Follow-up

Participants are monitored for smoking cessation at 3, 6, and 12 months

12 months

Follow-up assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Quit2Heal Smartphone App
• QuitGuide App

Trial Overview The study compares two smoking cessation apps: Quit2Heal and QuitGuide. Both offer strategies to handle cravings, guides on quitting, staying smoke-free plans, and advice on choosing medications that help stop smoking. Patients will randomly receive one of these apps.

Participant Groups

Group I: Arm I (Quit2Heal app) Experimental Treatment 2 Interventions

Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

Group II: Arm II (QuitGuide app) Active Control 2 Interventions

Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

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]

A novel automated Patient Reported Outcomes (PRO) tobacco use screener was implemented in the electronic health record system, allowing 4589 cancer patients to be screened, with 3.6% identified as recent smokers.

Of those who screened positive, nearly 50% engaged in smoking cessation treatment, suggesting that this system may enhance the identification of smokers and improve treatment engagement compared to traditional methods in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Patient Reported Outcomes Measurement via the Electronic Health Record to Connect Patients with Cancer to Smoking Cessation Treatment. May, JR., Klass, E., Davis, K., et al.[2020]

A randomized controlled trial involving 137 cancer patients found that a motivational interviewing intervention did not significantly increase smoking cessation rates compared to usual care, with both groups showing low quit rates at 6 months (5% for intervention vs. 6% for control).

However, a sensitivity analysis suggested that the intervention group had a higher quit rate (29%) compared to the control group (18%), indicating that while the intervention may not have been statistically significant, it could still have potential benefits that warrant further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Wakefield, M., Olver, I., Whitford, H., et al.[2022]

Continued smoking after a cancer diagnosis significantly increases the risk of mortality and second primary cancers, highlighting the importance of effective smoking cessation strategies for cancer patients.

In a study involving 134 current smokers identified from a cancer clinic, only 12 enrolled in a patient navigation intervention, with only 6 engaging in cessation treatment, indicating that while patients found the intervention satisfactory, the low recruitment rates suggest challenges in implementing this approach effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. Fan, T., Yingst, JM., Bascom, R., et al.[2022]

The NRT2Quit smartphone app showed preliminary evidence of improving short-term smoking cessation rates and adherence to nicotine replacement therapy (NRT), with a biochemically verified quit rate of 25% in the intervention group compared to 8% in the control group, although the results were not statistically significant due to low participant numbers.

Participants using the NRT2Quit app logged in more frequently and were more likely to use NRT at follow-up (100% vs. 28.6%), suggesting that the app may enhance engagement and support for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study. Herbec, A., Brown, J., Shahab, L., et al.[2023]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

An Implementation Trial to Improve Tobacco Treatment for Cancer Patients: Patient Preferences, Treatment Acceptability and Effectiveness. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Leveraging Patient Reported Outcomes Measurement via the Electronic Health Record to Connect Patients with Cancer to Smoking Cessation Treatment. [2020]

4. 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]

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

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

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

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. [2021]