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Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

Primary Purpose

Cancer, Tobacco Dependence, Tobacco Use Cessation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CareConnect
AutoReach
Biospecimen samples
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer focused on measuring Interactive Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CareConnect (Intervention)

AutoReach (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 13, 2023
Last Updated
October 16, 2023
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT05829824
Brief Title
Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach
Official Title
Connect Cancer Patients to Tobacco Cessation Care by Automated Interactive Outreach
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 biochemical 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 biological samples taken (saliva and breath). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Tobacco Dependence, Tobacco Use Cessation
Keywords
Interactive Intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CareConnect (Intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
AutoReach (Control)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CareConnect
Other Intervention Name(s)
Automated Interactive Outreach
Intervention Description
A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)
Intervention Type
Other
Intervention Name(s)
AutoReach
Other Intervention Name(s)
Automated Interactive Outreach
Intervention Description
Phone call / SMS Text
Intervention Type
Procedure
Intervention Name(s)
Biospecimen samples
Other Intervention Name(s)
Biological Specimens
Intervention Description
Saliva and breath sample
Primary Outcome Measure Information:
Title
Proportion of participants who report using any smoking cessation resources
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Proportion of participants who started the call and chose the referrals
Description
Proportion of participants who started the call and chose the referrals to quitline/speaking with a tobacco treatment specialist or to use smokefree.gov
Time Frame
Up to 3 months
Title
Mean Satisfaction Ratings (CareConnect Group Only)
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edgar Yu
Phone
877-827-3222
Email
Edgar.Yu@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Tsoh, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Yu
Email
Edgar.Yu@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Janice Tsoh, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

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