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CompletedNCT05829824Updated Feb 13, 2026

Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

An interventional study of CareConnect and AutoReach in Cancer, Tobacco Dependence and Tobacco Use Cessation, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer.

Read the detailed description

PRIMARY OBJECTIVE:

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.

02

Conditions studied

  • Cancer
  • Tobacco Dependence
  • Tobacco Use Cessation

Keywords

  • Interactive Intervention
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 400 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18 years and older.
  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

Exclusion Criteria:

  1. Contraindication to any study-related procedure or assessment.
  2. No valid contact telephone number.
  3. Currently hospitalized or having been discharged from inpatient setting within the past month (according to EHR).
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: CareConnect · Procedure: Biospecimen samples

  • Other
    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.

    Other: AutoReach · Procedure: Biospecimen samples

Interventions

  • BehavioralCareConnect

    A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)

    Also known as: Automated Interactive Outreach

  • OtherAutoReach

    Phone call / SMS Text

    Also known as: Automated Interactive Outreach

  • ProcedureBiospecimen samples

    Optional saliva sample

    Also known as: Biological Specimens

06

What researchers measure

Primary outcomes

  1. Proportion of participants who report using any smoking cessation resources

    Self-reported receipts (recorded as 'yes' or 'no') of evidence-based, smoking cessation services assessed at 3 months post-intervention will be reported as a proportion.

    Time frame: Up to 3 months

Secondary outcomes

  1. Proportion of participants who started the call and chose the referrals

    Proportion of participants who started the call and chose the referrals to quitline/speaking with a tobacco treatment specialist or to use smokefree.gov

    Time frame: Up to 3 months

  2. Mean Satisfaction Ratings (CareConnect Group Only)

    Participants in the CareConnect intervention group will be asked to respond to the following single item to measure overall satisfaction with the CareConnect intervention from answers to the following question "How helpful was the call you received about tobacco use and cancer care?". The response to this single item is scored on a range from 0= 'Not at all helpful' to 4= 'Extremely helpful'. Higher scores indicate a greater degree of satisfaction.

    Time frame: Up to 3 months

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829824
Lead sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
Nov 27, 2023
Primary completion
May 7, 2025
Completion
Aug 15, 2025
Last update
Feb 13, 2026

Study contacts

Janice Tsoh, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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