Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach
NCT ID: NCT05829824
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-11-27
2025-06-30
Brief Summary
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Detailed Description
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I. To evaluate CareConnect's efficacy on referring patients to tobacco cessation resources.
SECONDARY OBJECTIVE:
I. To evaluate patients' acceptance of referrals.
II. To evaluate the acceptability of CareConnect.
EXPLORATORY OBJECTIVES:
I. In-depth semi-structured qualitative interviews of 20 selectively chosen participants who completed the 3-month follow-up survey or finished the automated CareConnect or Auto-Reach call but may have refused to complete the 3-month follow-up survey (10 from each group).
II. Smoking cessation with verification.
OUTLINE:
Eligible participants, identified through the Cancer Center Tobacco Registry will be randomized to either the Intervention or Control arm on a 1:1 ratio. Participants who complete the first call of CareConnect or AutoReach will be considered enrolled. Participants will complete a baseline assessment, a 3-month assessment, and have option to provide a saliva sample.
For those who are selected to participate in an in-depth interview, this will take place within 1 month after the 3-month assessment. Data from the participants medical record may be accessed at 6 months post follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CareConnect (Intervention)
Participants will receive automated 'CareConnect' calls/SMS text at enrollment. The call protocol includes up to 2 calls on 2 consecutive days if no response to first call. If there is no response to call, a follow up SMS 3-4 days later. Each CareConnect contact will include (1) assessment, (2) motivational enhancement tailored to participants' tobacco use status and importance of quitting; and (3) multiple referral options (UCSF Fontana Tobacco Treatment Center (FTTC)/tobacco treatment specialist, Quitline, or smoke-freeTXT from smokefree.gov), offered after the motivational enhancement message. CareConnect will notify UCSF tobacco treatment specialist of participants acceptance of any of referral options. Referral options will be documented by specialists on the participants electronic health record (EHR). Participants who have completed the CareConnect call will be contacted by research staff for a 3-month survey to be completed online, by telephone, or postal mail.
CareConnect
A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)
Biospecimen samples
Optional saliva sample
AutoReach (Control)
Participants will receive automated AutoReach calls/Short Message Service (SMS) text at enrollment provides one referral option (speaking with a tobacco treatment specialist) and an option for sending information on cessation resources. All participants who have completed the AutoReach call will be contacted by research staff for a 3-month survey to be completed online, by telephone or postal mail.
AutoReach
Phone call / SMS Text
Biospecimen samples
Optional saliva sample
Interventions
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CareConnect
A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)
AutoReach
Phone call / SMS Text
Biospecimen samples
Optional saliva sample
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able 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. English, Spanish, Cantonese, or Mandarin speaking.
5. Self-reported current use of tobacco, including e-cigarette on EHR.
6. Has a diagnosis of cancer.
7. Has been seen by a prescribing provider within a UCSF Cancer Center-affiliated clinical department within the past 3 months.
Exclusion Criteria
2. No valid contact telephone number.
3. Currently hospitalized or having been discharged from inpatient setting within the past month (according to EHR).
18 Years
ALL
No
Sponsors
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Tobacco Related Disease Research Program
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Janice Tsoh, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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NCI-2023-03215
Identifier Type: REGISTRY
Identifier Source: secondary_id
226310
Identifier Type: -
Identifier Source: org_study_id
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