Cancer, Tobacco Dependence, Tobacco Use Cessation
Conditions
Keywords
Interactive Intervention
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 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.
Interventions
BEHAVIORALCareConnect
A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR)
OTHERAutoReach
Phone call / SMS Text
PROCEDUREBiospecimen samples
Optional saliva sample
Sponsors
University of California, San Francisco
Tobacco Related Disease Research Program
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who report using any smoking cessation resources | Up to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who started the call and chose the referrals | Up to 3 months | 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) | Up to 3 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJanice Tsoh, PhD
University of California, San Francisco
Outcome results
None listed