Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients

NCT05021185 | Completed DMC

• 2 other identifiers: 21727NCI-2021-09058
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Tobacco Dependence; Tobacco Use Cessation; Cancer

Keywords

Interactive Mobile Application; Radiation Therapy; Radiation Oncology; Smoking Cessation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  Up to 3 months

Secondary Outcomes (2)

• Proportions of participants with reported abstinence

  Up to 3 months

• Proportion of iMD participants who indicate requests of referral for smoking cessation

  Up to 9 months

Study Arms (2)

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

Other: Interactive Mobile Doctor (iMD)

Control Group

NO INTERVENTION

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

Interventions

Interactive Mobile Doctor (iMD) OTHER

Video educational tool

Interactive Mobile Doctor (iMD) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation; Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Janice Tsoh, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: November 15, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)