Quit2Heal App for Smoking Cessation in Cancer Patients

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two smartphone apps designed to help cancer patients quit smoking. The researchers compare Quit2Heal to QuitGuide to determine which app more effectively aids smoking cessation. Both apps provide support, including coping strategies, quitting guides, and medication advice. This trial suits individuals diagnosed with cancer in the past two years who have smoked recently, wish to quit, and own a smartphone. Participants should feel comfortable using apps and be willing to complete follow-up surveys over the next year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows no specific safety data for the Quit2Heal app. However, as a smartphone app designed to help people stop smoking, it is not expected to cause physical side effects like medication might. The app assists cancer patients in quitting smoking by offering coping tools and support.

The QuitGuide app has been widely used to help people quit smoking, with no known safety concerns. Both apps support users in quitting smoking, which is generally safe when following recommended guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Quit2Heal app because it offers a tailored approach specifically for cancer patients who smoke. Unlike generic smoking cessation aids like nicotine replacement therapies or general quit-smoking apps, Quit2Heal is designed to address the unique challenges faced by individuals with cancer. This app provides targeted support and resources, potentially making it more effective for this group. By focusing on the specific needs of cancer patients, it aims to improve quit rates and overall health outcomes in a way that standard options may not.

What evidence suggests that this trial's treatments could be effective for smoking cessation in cancer patients?

Research shows that the Quit2Heal app is designed specifically for cancer patients who want to stop smoking. It addresses feelings like shame, stigma, depression, and anxiety, which are common among cancer patients who smoke. An earlier study found the app effective in helping users quit smoking, and it was well-received by those who used it. In this trial, participants will join one of two groups: one group will use the Quit2Heal app, which focuses on the unique challenges cancer patients face to help more people quit smoking, while the other group will use the QuitGuide app. This personalized approach of the Quit2Heal app may enhance its effectiveness in helping cancer patients quit smoking. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan B Bricker

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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.

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10283347/

Protocol of the Quit2Heal Randomized Controlled Trial - PMC The primary aim of the Quit2Heal trial is to determine whether Quit2Heal has significantly higher self-reported 30-day PPA at 12 months relative to QuitGuide.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001039

Efficacy of smartphone applications to help cancer patients ... Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting.

3. formative.jmir.org formative.jmir.org/2020/1/e16652/

A Smartphone App Designed to Help Cancer Patients Stop ... In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04409236

Quit2Heal Smartphone App in Helping Cancer Patients ... This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to the QuitGuide app in helping cancer patients quit smoking. Both ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37040817/

Protocol of the Quit2Heal randomized controlled trial Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6996729/

A Smartphone App Designed to Help Cancer Patients Stop ... Quit2Heal [56,57] is specifically designed to help cancer patients stop smoking by providing skills to cope with cancer-related shame, stigma, ...

7. withpower.com withpower.com/trial/quit2heal-app-for-smoking-cessation-in-cancer-patients-797e5

Quit2Heal App for Smoking Cessation in Cancer Patients 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 ...

8. play.google.com play.google.com/store/apps/details?id=org.fredhutch.quit2healcontrol&hl=en_US

Quit2Heal A - Apps on Google Play Quit2Heal is a quit smoking app available to individuals who are a part of the Quit2Heal research study. The app provides tips on staying motivated to quit, ...

9. quit2heal.org quit2heal.org/

Welcome to Quit2Heal Join Quit2Heal, a study comparing two smartphone apps for cancer patients quitting smoking. Begin with just a click.