Proactive Care Coordination for Cancer Survivors Who Smoke

Study Overview
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Brief Summary
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This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.

Official Title
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Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Online Referral NYS Quitline
* Behavioral: Tobacco cessation counseling and coordination of cessation medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD 9 cancer diagnosis seen at each site in the past two years Documentation of current smoking in the cancer registry. Exclusion Criteria: Dementia Stage IV or Stage IIIB cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proactive mailed care coordination<br> | Behavioral: Online Referral NYS Quitline<br>* Care coordinator will make an online referral to the NYS Quitline.<br>|
| Active Comparator: Proactive telephone care coordination.<br> | Behavioral: Tobacco cessation counseling and coordination of cessation medications<br>* Care coordinator will obtain verbal consent to transfer the patient to the NYS Quitline via 3-way call (warm transfer). The care coordinator will also assist the patient in obtaining NRT from a regular care provider, then call the patient every three months for 12 months to assess current smoking and offer to help smokers obtain additional cessation counseling and medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemically validated 7-day abstinence |  | 6 Months, 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, cancer, cancer registry, smoking cessation