Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

Connect Cancer Patients to Tobacco Cessation Care 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Tobacco Use Cessation; Tobacco Dependence
• Intervention / Treatment: Behavioral: CareConnect; Other: AutoReach; Procedure: Biospecimen samples

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 randomly selected participants who completed the 3-month follow-up call (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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edgar Yu; Phone Number: 877-827-3222; Email: Edgar.Yu@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Edgar Yu; Email: Edgar.Yu@ucsf.edu
      • Principal Investigator: Janice Tsoh, PhD
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CareConnect (Intervention); Participants will receive automated 'CareConnect' calls/SMS text at enrollment. The call protocol will include up to 2 calls on 2 consecutive days if no response to the 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 smokefreeTXT from smokefree.gov), offered after the motivational enhancement message. CareConnect will notify the UCSF tobacco treatment specialist of participants acceptance of any of the referral options. Referral options will be documented by the specialist on the participants electronic health record (EHR). All participants who have completed the CareConnect call will be contacted by research staff for a 3-month survey to be completed online or by telephone.	Behavioral: CareConnect; A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR); Other Names: Automated Interactive Outreach; Procedure: Biospecimen samples; Optional saliva sample; Other Names: Biological Specimens
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 or by telephone.	Other: AutoReach; Phone call / SMS Text; Other Names: Automated Interactive Outreach; Procedure: Biospecimen samples; Optional saliva sample; Other Names: Biological Specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 3 months
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.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program
• Investigators: Principal Investigator: Janice Tsoh, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Interactive Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 226310; NCI-2023-03215 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No