Proactive Care Coordination for Cancer Survivors Who Smoke | NCT02723656

Studies
Proactive Care Coordination for Cancer Survivors Who Smoke

NCT02723656

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Dec 11, 2018Actual

Enrollment

581Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Online Referral NYS Quitline
Tobacco cessation counseling and coordination of cessation medications

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Sep 29, 2018Actual

Completion Date

Sep 29, 2018Actual

First Submitted Date

Mar 24, 2016

First Submission Date that Met QC Criteria

Mar 24, 2016

First Posted Date

Mar 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2018

Last Update Posted Date

Dec 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

581Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proactive mailed care coordination	Active Comparator		Behavioral: Online Referral NYS Quitline
Proactive telephone care coordination.	Active Comparator		Behavioral: Tobacco cessation counseling and coordination of cessation medications

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Online Referral NYS Quitline	Behavioral	Care coordinator will make an online referral to the NYS Quitline.	Proactive mailed care coordination

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Krebs, MD	New York University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D012907	Smoking
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D001519	Behavior
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided