Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

NCT ID: NCT05829824

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Tobacco Dependence Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CareConnect

Intervention Type BEHAVIORAL

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

Biospecimen samples

Intervention Type PROCEDURE

Optional saliva sample

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.

Group Type OTHER

AutoReach

Intervention Type OTHER

Phone call / SMS Text

Biospecimen samples

Intervention Type PROCEDURE

Optional saliva sample

Interventions

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CareConnect

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

Intervention Type BEHAVIORAL

AutoReach

Phone call / SMS Text

Intervention Type OTHER

Biospecimen samples

Optional saliva sample

Intervention Type PROCEDURE

Other Intervention Names

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Automated Interactive Outreach Automated Interactive Outreach Biological Specimens

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tobacco Related Disease Research Program

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janice Tsoh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Edgar Yu

Role: CONTACT

877-827-3222

Facility Contacts

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Edgar Yu

Role: primary

Role: backup

877-827-3222

Other Identifiers

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NCI-2023-03215

Identifier Type: REGISTRY

Identifier Source: secondary_id

226310

Identifier Type: -

Identifier Source: org_study_id

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