Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

Cancer Clinical Trial

Official title:

Connect Cancer Patients to Tobacco Cessation Care by Automated Interactive Outreach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829824
• Other study ID #: 226310
• Secondary ID: NCI-2023-03215
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Edgar Yu
• Phone: 877-827-3222
• Email: Edgar.Yu[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Tobacco Dependence
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

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

Other:
• AutoReach
Phone call / SMS Text

Procedure:
• Biospecimen samples
Optional saliva sample

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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