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

Primary Purpose

Tobacco Dependence, Tobacco Use Cessation, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Mobile Doctor (iMD)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Dependence focused on measuring Interactive Mobile Application, Radiation Therapy, Radiation Oncology, Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or order
  2. Ability to understand study procedures and to comply with them for the entire length of the study.
  3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
  4. Started the CT simulation procedure (about to initiate radiation therapy) or currently receiving radiation treatment for cancer at a University of California, San Francisco (UCSF) location (Mission Bay, Mount Zion, Parnassus, etc.).
  5. Reported using cigarettes, e-cigarette or any tobacco product(s) in the past 12 months

Exclusion Criteria:

  1. Contraindication to any study-related procedure or assessment.
  2. Participated in Patient/Care Team Advisory Board Activities for the project
  3. Hearing and/or vision disabilities in receiving the iMD intervention or follow-up assessment such as videos or telephone interviews at follow-up
  4. Cancer care team's judgement of inappropriateness due to cognitive or medical reasons
  5. Inability to understand spoken and written English
  6. Completion of radiation therapy for cancer at time of enrollment

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interactive Mobile Doctor (iMD) Intervention

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

Proportions of participants with reported abstinence
Proportions of participants with self-report + biochemically verified tobacco abstinence (salivary cotinine or exhaled CO)
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

Full Information

First Posted
August 19, 2021
Last Updated
November 29, 2022
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT05021185
Brief Title
Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients
Official Title
Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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: 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 are initiating or receiving 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Tobacco Use Cessation, Cancer
Keywords
Interactive Mobile Application, Radiation Therapy, Radiation Oncology, Smoking Cessation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interactive Mobile Doctor (iMD) Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will complete questionnaires and receive a handout containing tobacco cessation resources.
Intervention Type
Other
Intervention Name(s)
Interactive Mobile Doctor (iMD)
Intervention Description
Video educational tool
Primary Outcome Measure Information:
Title
Proportion of eligible individuals who consent to enroll in the study
Description
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
Title
Proportion of participants assigned to iMD intervention with a response to referral question
Description
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
Title
Proportion of iMD participants who complete 2 or more sessions
Description
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
Title
Median scores on the perceived helpfulness of the iMD program
Description
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
Secondary Outcome Measure Information:
Title
Proportions of participants with reported abstinence
Description
Proportions of participants with self-report + biochemically verified tobacco abstinence (salivary cotinine or exhaled CO)
Time Frame
Up to 3 months
Title
Proportion of iMD participants who indicate requests of referral for smoking cessation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Started the CT simulation procedure (about to initiate radiation therapy) 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janice Tsoh
Phone
(415) 502-8438
Email
Janice.Tsoh@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Tsoh, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Yu
Email
Edgar.Yu@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Janice Tsoh, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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