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Completed

NCT Number: NCT05829824

Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

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.

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Key information

Conditions

Cancer Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Neoplasms Substance-Related Disorders Tobacco Dependence Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

CareConnect

Behavioral

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

Other names: Automated Interactive Outreach

AutoReach

Other

Phone call / SMS Text

Other names: Automated Interactive Outreach

Biospecimen samples

Procedure

Optional saliva sample

Other names: Biological Specimens

Primary outcomes

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

    Time frame: Up to 3 months

    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.

Secondary outcomes

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

    Time frame: Up to 3 months

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

  2. Mean Satisfaction Ratings (CareConnect Group Only)

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Official study title

Connect Cancer Patients to Tobacco Cessation Care by Automated Interactive Outreach

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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