Proactive Care Coordination for Cancer Survivors Who Smoke

NCT ID: NCT02723656

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 581 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-09-29

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Proactive mailed care coordination

Group Type: ACTIVE_COMPARATOR

Online Referral NYS Quitline

Intervention Type: BEHAVIORAL

Care coordinator will make an online referral to the NYS Quitline.

Proactive telephone care coordination.

Group Type: ACTIVE_COMPARATOR

Tobacco cessation counseling and coordination of cessation medications

Intervention Type: BEHAVIORAL

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.

Interventions

Online Referral NYS Quitline

Care coordinator will make an online referral to the NYS Quitline.

Intervention Type: BEHAVIORAL

Tobacco cessation counseling and coordination of cessation medications

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Krebs, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-01069

Identifier Type: -

Identifier Source: org_study_id