Proactive Care Coordination for Cancer Survivors Who Smoke

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723656
• Other study ID #: 15-01069
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 29, 2018

Study information

• Verified date: December 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: September 29, 2018
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Online Referral NYS Quitline
Care coordinator will make an online referral to the NYS Quitline.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	biochemically validated 7-day abstinence		6 Months, 12 Months