Proactive Care Coordination for Cancer Survivors Who Smoke

NCT02723656 | Completed

• 1 other identifier: 15-01069
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 1

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

Keywords

smoking; cancer; cancer registry; smoking cessation

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• biochemically validated 7-day abstinence

  6 Months, 12 Months

Study Arms (2)

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

Online Referral NYS Quitline BEHAVIORAL

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

Proactive mailed care coordination

Tobacco cessation counseling and coordination of cessation medications 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.

Proactive telephone care coordination.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dementia
• Stage IV or Stage IIIB cancer

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Neoplasms; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Paul Krebs, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: September 29, 2018
• Study Completion: September 29, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

US (1)