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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03215 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CareConnect (Intervention) | Experimental | 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. |
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| AutoReach (Control) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareConnect | Behavioral | A combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Satisfaction Ratings (CareConnect Group Only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Tsoh, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| AutoReach | Other | Phone call / SMS Text |
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| Biospecimen samples | Procedure | Optional saliva sample |
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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 |
| D001519 | Behavior |