iMD for Quitting Smoking in Cancer Patients

Overseen By Janice Tsoh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Hearing disabilities, Vision disabilities, Cognitive reasons, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool called the Interactive Mobile Doctor (iMD) to help cancer patients quit smoking during radiation therapy. The goal is to support patients in stopping smoking or staying smoke-free through video education and personalized messages. Participants will either receive the iMD intervention or complete questionnaires and receive a resource handout. The trial seeks cancer patients at UCSF who have used tobacco in the past 12 months and are about to start or are currently undergoing radiation treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for cancer patients trying to quit smoking.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Interactive Mobile Doctor (iMD) is safe for cancer patients?

Research shows that digital tools like the Interactive Mobile Doctor (iMD) can help cancer patients quit smoking. These programs have demonstrated positive effects, even if they are small, meaning they can assist in quitting smoking, though results might not be dramatic.

The iMD is a smartphone program similar to an app, providing guidance through messages and videos. These programs are generally considered safe because they don't involve medication or physical treatments, and no serious side effects have been reported.

This study is in an early stage, called a pilot study, which primarily examines how well the tool works and if users find it appealing. Early stages usually focus on safety, with minimal risk involved. Overall, the iMD offers a low-risk way to aid in quitting smoking, especially for those receiving cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Interactive Mobile Doctor (iMD) for quitting smoking in cancer patients because it offers a personalized, tech-driven approach. Unlike traditional methods like nicotine replacement therapy or counseling, iMD utilizes interactive sessions that adapt to the patient's responses, making the experience more engaging and tailored. The use of computerized assessments, personalized video messages, and summary printouts delivered via tablet makes it a unique and accessible option, potentially increasing the effectiveness of smoking cessation efforts during a critical period for cancer patients.

What evidence suggests that the Interactive Mobile Doctor (iMD) is effective for smoking cessation in cancer patients?

Research has shown that digital tools can help people quit smoking, especially cancer survivors. In this trial, participants in the Interactive Mobile Doctor (iMD) Intervention arm will receive personalized videos and quizzes tailored to individual needs to encourage quitting. Although the benefits are small, they show promise in aiding smoking cessation. A study with similar digital tools found that patients felt more supported and informed about the dangers of smoking. Overall, these tools aim to assist people in quitting smoking, even when facing challenges like cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Janice Tsoh, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults who can consent to participate, understand the study, and will follow it through. They must have used tobacco in the past year and be starting or currently receiving radiation therapy for cancer at UCSF. People with contraindications, cognitive or medical issues as judged by their care team, hearing/vision disabilities affecting intervention participation, or those already done with radiation therapy cannot join.

Inclusion Criteria

Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

I am starting or currently undergoing radiation therapy for cancer at a UCSF location.

I understand and can follow the study's procedures.

Exclusion Criteria

Inability to understand spoken and written English

I have no health issues preventing me from undergoing study procedures.

I have finished my radiation therapy for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 3 iMD sessions prior to their completion of radiation therapy, including computerized assessments and tailored videos

Up to 3 months

3 sessions (in-person or virtual)

Follow-up

Participants are monitored for tobacco abstinence and referral requests after treatment

3 months

Long-term follow-up

Participants are monitored for additional outcomes such as referral requests and abstinence

Up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Interactive Mobile Doctor (iMD)

Trial Overview The study is testing an educational video tool called Interactive Mobile Doctor (iMD) designed to help cancer patients undergoing radiation at UCSF quit smoking or maintain abstinence from tobacco use during their treatment.

How Is the Trial Designed?

Group I: Interactive Mobile Doctor (iMD) Intervention Experimental Treatment 1 Intervention

Participants will receive up to a total of 3 iMD sessions prior to their completion of radiation therapy; each session will take about 10-15 minutes and includes: 1) computerized assessments that will be delivered on the screen via text with accompanying audio and participants will respond directly on the tablet 2) tailored videos that deliver messages specific to patient's responses to selected assessment questions and 3) a summary printout

Group II: Control Group Active Control 1 Intervention

Participants will complete questionnaires and receive a handout containing tobacco cessation resources.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05021185

NCT05021185 | Interactive Mobile Doctor (iMD) to Promote ... This study is the first to address tobacco use among can patients receiving radiation therapy that targets both tobacco cessation (current users) and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11229662/

Digital Smoking Cessation Intervention for Cancer Survivors Recent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors.

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

Protocol of the Quit2Heal Randomized Controlled Trial - PMC Quit2Heal is designed to address cancer-related shame, stigma, depression, anxiety, and knowledge about the consequences of smoking/quitting.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125007141

Real-World Comparison of Phone versus Video ... A systematic review of the literature on smoking cessation found no evidence of a difference in abstinence rates at 3 months in between phone ...

5. jabfm.org jabfm.org/content/jabfp/31/6/869.full.pdf

Interactive Mobile Doctor (iMD) to Promote Patient-Provider ... Results: Among 47 male daily smokers (87% participation rate), 98% were limited English proficient and 53% had no intent to quit smoking within 6 months. On ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05253573

Study Details | NCT05253573 | Mobile Health Technology ... This mHealth automated treatment (AT) approach includes a fully automated, interactive, personalized, smartphone-based intervention for behavioral treatment, ...

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

Efficacy of smartphone applications to help cancer patients ... Remotely delivered behavioral programs for smoking cessation such as smartphone applications (“apps”) may provide a low-cost alternative to in-clinic programs ...

8. jmir.org jmir.org/2020/3/e16907/

A Mobile Just-in-Time Adaptive Intervention for Smoking ... The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk ...

9. researchprotocols.org researchprotocols.org/2025/1/e66517

Mobile Health Technology for Personalized Tobacco ... Objective: This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and preliminary efficacy of our mobile health–based ...