An interventional study of Interactive Mobile Doctor (iMD) in Tobacco Dependence, Tobacco Use Cessation and Cancer, sponsored by University of California, San Francisco. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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).
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:
I. 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:
I. 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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 30 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Interactive Mobile Doctor (iMD)
Participants will complete questionnaires and receive a handout containing tobacco cessation resources.
Video educational tool
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 3 months
Proportions of participants with reported abstinence
Proportions of participants with self-report + biochemically verified tobacco abstinence (salivary cotinine or exhaled CO)
Time frame: 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
Time frame: Up to 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco