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Trial Title:
Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach
NCT ID:
NCT05829824
Condition:
Cancer
Tobacco Dependence
Tobacco Use Cessation
Conditions: Official terms:
Tobacco Use Disorder
Conditions: Keywords:
Interactive Intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CareConnect
Description:
A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)
Arm group label:
CareConnect (Intervention)
Other name:
Automated Interactive Outreach
Intervention type:
Other
Intervention name:
AutoReach
Description:
Phone call / SMS Text
Arm group label:
AutoReach (Control)
Other name:
Automated Interactive Outreach
Intervention type:
Procedure
Intervention name:
Biospecimen samples
Description:
Optional saliva sample
Arm group label:
AutoReach (Control)
Arm group label:
CareConnect (Intervention)
Other name:
Biological Specimens
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 selectively chosen 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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edgar Yu
Email:
Edgar.Yu@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Janice Tsoh, PhD
Email:
Principal Investigator
Start date:
November 27, 2023
Completion date:
January 30, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Tobacco Related Disease Research Program
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05829824
