Tobacco DependenceNCT05021185
Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients
A study testing Interactive Mobile Doctor (iMD) in people with Tobacco Dependence and Tobacco Use Cessation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The proposed pilot study aims to develop and test a patient video educational tool, an interactive Mobile Doctor (iMD), that can be integrated in radiation oncology setting to effectively engage cancer patients receiving treatment at University of California, San Francisco (UCSF) to facilitate smoking cessation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence, Tobacco Use Cessation, Cancer
- What is being tested?
- Interactive Mobile Doctor (iMD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or order
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Scheduled for a consultation visit with an oncologist to prepare for a radiation therapy for cancer treatment or currently receiving radiation treatment for cancer at a University of California, San Francisco (UCSF) location (Mission Bay, Mount Zion, Parnassus, etc.).
- Reported using cigarettes, e-cigarette or any tobacco product(s) in the past 12 months
Who cannot join
- Contraindication to any study-related procedure or assessment.
- Participated in Patient/Care Team Advisory Board Activities for the project
- Hearing and/or vision disabilities in receiving the iMD intervention or follow-up assessment such as videos or telephone interviews at follow-up
- Cancer care team's judgement of inappropriateness due to cognitive or medical reasons
- Inability to understand spoken and written English
- Completion of radiation therapy for cancer at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The proposed pilot study aims to develop and test a patient video educational tool, an interactive Mobile Doctor (iMD), that can be integrated in radiation oncology setting to effectively engage cancer patients receiving treatment at University of California, San Francisco (UCSF) to facilitate smoking cessation and maintaining smoking abstinence in the context of their radiation treatment.
This study is the first to address tobacco use among can patients receiving radiation therapy that targets both tobacco cessation (current users) and maintaining abstinence (former users who have recently quit).
Read the detailed description
The interactive Mobile Doctor (iMD) is an interactive video educational program that delivers tailored messages in response to participants' input, generates a summary report providing tobacco use status and cessation resources and solicits participants' interest in receiving referral or information to tobacco cessation resources.
PRIMARY OBJECTIVE:
- To assess the feasibility and acceptability of the interactive Mobile Doctor (iMD), an interactive patient education tool, utilizing patient-centered and interactive technology approaches to target cancer patients who report using tobacco within the past 12 months and who are receiving or planning to receive radiation therapy for cancer.
SECONDARY OBJECTIVES:
- To assess preliminary efficacy of iMD on tobacco abstinence when compared to the control (assessment + resource information only).
II. To estimate impacts of iMD on referral requests.
Participants will be randomized to either the iMD or Control Group in a 1:1 ratio, stratified by tobacco use status within past 30 days (current vs former tobacco users), to the iMD intervention or the control group
iMD Intervention Participants: Participants receive up to a total of 3 iMD sessions prior to their completion of radiation therapy (RT). The iMD session will take about 10-15 minutes and will include: 1) computerized assessments(tobacco use in past 12 months and in past 30 days; types of tobacco used, time to first cigarette or tobacco use, cigarettes used per day on a typical day of use, readiness for quitting, and concerns about quitting smoking) 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, including addressing misconceptions of being too late to quit smoking after cancer diagnosis, which could be a barrier for quitting smoking, or tobacco-free is not necessary after completion of RT; and 3) a summary printout, the iMD Summary Reported generated at the end of each iMD session will provide a summary of a participant's RT completion status or anticipated completion date, tobacco use status, plans for quitting or commitment to abstinence, key messages addressing participants' concerns and uniform resource locator (URL)s of the videos watched, California Smokers' Helpline website and telephone numbers, and interest to be contacted by a tobacco treatment specialist or in receiving for tobacco use, referred to tobacco treatment resources.
Control Group Participants: Participants will undergo the assessment questions. Instead of viewing and participating in the interactive video education about tobacco cessation or tobacco-free living, will participants receive a handout containing tobacco cessation resources.
Participants will be followed up for 3 month after their first visit.
- Conditions
- Tobacco Dependence, Tobacco Use Cessation, Cancer
- Being tested
- Interactive Mobile Doctor (iMD)
- Keywords
- Interactive Mobile Application, Radiation Therapy, Radiation Oncology, Smoking Cessation
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation, Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Mobile Doctor (iMD)Other
Video educational tool
| Study group | Role | What they receive |
|---|---|---|
| Interactive Mobile Doctor (iMD) Intervention | Experimental | 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 Receives: Other: Interactive Mobile Doctor (iMD) |
| Control Group | No intervention | Participants will complete questionnaires and receive a handout containing tobacco cessation resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible individuals who consent to enroll in the study
The proportion of participants who consent to enroll from the total number who are approached for eligibility will be reported.
Measured: Up to 6 months
Proportion of participants assigned to iMD intervention with a response to referral question
The proportion of participants assigned to iMD intervention who have a recorded response to the question on referral to a smoking cessation treatment service/ resource will be reported.
Measured: Up to 3 months
Proportion of iMD participants who complete 2 or more sessions
The proportion of participants enrolled in the iMD arm who complete at least 2 or more of the iMD sessions will be reported.
Measured: Up to 3 months
Median scores on the perceived helpfulness of the iMD program
The perceived helpfulness of the iMD program will be measured using a 5-point likert scale a a response to the question provided to the participants who are assigned to the iMD arm which rates the helpfulness of the intervention as 1='Somewhat helpful" to 5="Very helpful
Measured: Up to 3 months
Secondary outcomes (2)
Proportions of participants with reported abstinence
Proportions of participants with self-report + biochemically verified tobacco abstinence (salivary cotinine or exhaled CO)
Measured: Up to 3 months
Proportion of iMD participants who indicate requests of referral for smoking cessation
The investigators will estimate impacts of iMD on yield referral requests (when participants respond "Yes" to be referred for smoking cessation related services) for participants assigned to the iMD program
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Nov 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Janice Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021185
- Sponsor's protocol ID
- 21727
- Other IDs
- NCI-2021-09058
- Status last verified
- May 2025
- First submitted
- 19 Aug 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients
- ClinicalTrials.gov ID
- NCT05021185
- Acronym / sponsor ID
- 21727
- Conditions
- Tobacco Dependence, Tobacco Use Cessation, Cancer
- Keywords
- Interactive Mobile Application, Radiation Therapy, Radiation Oncology, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed pilot study aims to develop and test a patient video educational tool, an interactive Mobile Doctor (iMD), that can be integrated in radiation oncology setting to effectively engage cancer patients receiving treatment at University of California, San Francisco (UCSF) to facilitate smoking cessation and maintaining smoking abstinence in the context of their radiation treatment.
This study is the first to address tobacco use among can patients receiving radiation therapy that targets both tobacco cessation (current users) and maintaining abstinence (former users who have recently quit).
Detailed description
The interactive Mobile Doctor (iMD) is an interactive video educational program that delivers tailored messages in response to participants' input, generates a summary report providing tobacco use status and cessation resources and solicits participants' interest in receiving referral or information to tobacco cessation resources.
PRIMARY OBJECTIVE:
- To assess the feasibility and acceptability of the interactive Mobile Doctor (iMD), an interactive patient education tool, utilizing patient-centered and interactive technology approaches to target cancer patients who report using tobacco within the past 12 months and who are receiving or planning to receive radiation therapy for cancer.
SECONDARY OBJECTIVES:
- To assess preliminary efficacy of iMD on tobacco abstinence when compared to the control (assessment + resource information only).
II. To estimate impacts of iMD on referral requests.
Participants will be randomized to either the iMD or Control Group in a 1:1 ratio, stratified by tobacco use status within past 30 days (current vs former tobacco users), to the iMD intervention or the control group
iMD Intervention Participants: Participants receive up to a total of 3 iMD sessions prior to their completion of radiation therapy (RT). The iMD session will take about 10-15 minutes and will include: 1) computerized assessments(tobacco use in past 12 months and in past 30 days; types of tobacco used, time to first cigarette or tobacco use, cigarettes used per day on a typical day of use, readiness for quitting, and concerns about quitting smoking) 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, including addressing misconceptions of being too late to quit smoking after cancer diagnosis, which could be a barrier for quitting smoking, or tobacco-free is not necessary after completion of RT; and 3) a summary printout, the iMD Summary Reported generated at the end of each iMD session will provide a summary of a participant's RT completion status or anticipated completion date, tobacco use status, plans for quitting or commitment to abstinence, key messages addressing participants' concerns and uniform resource locator (URL)s of the videos watched, California Smokers' Helpline website and telephone numbers, and interest to be contacted by a tobacco treatment specialist or in receiving for tobacco use, referred to tobacco treatment resources.
Control Group Participants: Participants will undergo the assessment questions. Instead of viewing and participating in the interactive video education about tobacco cessation or tobacco-free living, will participants receive a handout containing tobacco cessation resources.
Participants will be followed up for 3 month after their first visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Mobile Doctor (iMD) Intervention | Experimental | Other: Interactive Mobile Doctor (iMD)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 |
| Control Group | No intervention | –Participants will complete questionnaires and receive a handout containing tobacco cessation resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or order
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Scheduled for a consultation visit with an oncologist to prepare for a radiation therapy for cancer treatment or currently receiving radiation treatment for cancer at a University of California, San Francisco (UCSF) location (Mission Bay, Mount Zion, Parnassus, etc.).
- Reported using cigarettes, e-cigarette or any tobacco product(s) in the past 12 months
Key exclusion criteria (6 listed)
- Contraindication to any study-related procedure or assessment.
- Participated in Patient/Care Team Advisory Board Activities for the project
- Hearing and/or vision disabilities in receiving the iMD intervention or follow-up assessment such as videos or telephone interviews at follow-up
- Cancer care team's judgement of inappropriateness due to cognitive or medical reasons
- Inability to understand spoken and written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Mobile Doctor (iMD)Video educational tool | Other | Interactive Mobile Doctor (iMD) Intervention |
Primary outcome
Proportion of eligible individuals who consent to enroll in the study
Time frame: Up to 6 months
The proportion of participants who consent to enroll from the total number who are approached for eligibility will be reported.
Proportion of participants assigned to iMD intervention with a response to referral question
Time frame: Up to 3 months
The proportion of participants assigned to iMD intervention who have a recorded response to the question on referral to a smoking cessation treatment service/ resource will be reported.
Proportion of iMD participants who complete 2 or more sessions
Time frame: Up to 3 months
The proportion of participants enrolled in the iMD arm who complete at least 2 or more of the iMD sessions will be reported.
Median scores on the perceived helpfulness of the iMD program
Time frame: Up to 3 months
The perceived helpfulness of the iMD program will be measured using a 5-point likert scale a a response to the question provided to the participants who are assigned to the iMD arm which rates the helpfulness of the intervention as 1='Somewhat helpful" to 5="Very helpful
2 secondary outcomes
Proportions of participants with reported abstinence
Time frame: Up to 3 months
Proportion of iMD participants who indicate requests of referral for smoking cessation
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Tsoh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Mobile Doctor (iMD) in people with Tobacco Dependence and Tobacco Use Cessation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible individuals who consent to enroll in the study (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.