Proactive Care Coordination for Cancer Survivors Who Smoke

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Online Referral NYS Quitline; Behavioral: Tobacco cessation counseling and coordination of cessation medications

• Registration Number: NCT02723656
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Primary Completion: 2018-09-29
• Study Completion: 2018-09-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 581

Inclusion Criteria

• ICD 9 cancer diagnosis seen at each site in the past two years
• Documentation of current smoking in the cancer registry.

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Exclusion Criteria

• Dementia
• Stage IV or Stage IIIB cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive mailed care coordination	Online Referral NYS Quitline	-
Proactive telephone care coordination.	Tobacco cessation counseling and coordination of cessation medications	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
biochemically validated 7-day abstinence	6 Months, 12 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States