Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

NCT05829824 | Completed

• 2 other identifiers: 226310NCI-2023-03215
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Cessation; Cancer; Tobacco Dependence

Keywords

Interactive Intervention

Outcome Measures

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.

  Up to 3 months

Secondary Outcomes (2)

• Proportion of participants who started the call and chose the referrals

  Up to 3 months

• Mean Satisfaction Ratings (CareConnect Group Only)

  Up to 3 months

Study Arms (2)

CareConnect (Intervention)

EXPERIMENTAL

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

AutoReach (Control)

OTHER

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

Biospecimen samples PROCEDURE

Optional saliva sample

Also known as: Biological Specimens

AutoReach (Control); CareConnect (Intervention)

CareConnect BEHAVIORAL

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

Also known as: Automated Interactive Outreach

CareConnect (Intervention)

AutoReach OTHER

Phone call / SMS Text

Also known as: Automated Interactive Outreach

AutoReach (Control)

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older.
• Able 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.
• English, Spanish, Cantonese, or Mandarin speaking.
• Self-reported current use of tobacco, including e-cigarette on EHR.
• Has a diagnosis of cancer.
• Has been seen by a prescribing provider within a UCSF Cancer Center-affiliated clinical department within the past 3 months.

You may not qualify if:

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

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

Neoplasms; Tobacco Use Disorder; Tobacco Use 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: April 13, 2023
• First Posted: April 26, 2023
• Study Start: November 27, 2023
• Primary Completion: May 7, 2025
• Study Completion: August 15, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)