Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

Last updated: February 12, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tobacco Use Disorder

Cancer

Treatment

Biospecimen samples

CareConnect

AutoReach

Clinical Study ID

NCT05829824
226310
NCI-2023-03215
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years and older.

  2. Able to understand study procedures and to comply with them for the entire length ofthe study.

  3. Ability of individual or legal guardian/representative to understand a writteninformed 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-affiliatedclinical department within the past 3 months.

Exclusion

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 thepast month (according to EHR).

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Biospecimen samples
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

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