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OpenTrials
Completed

NCT Number: NCT02723656

Proactive Care Coordination for Cancer Survivors Who Smoke

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.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Smoking Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Referral NYS Quitline

Behavioral

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

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.

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

    Time frame: 12 Months

Secondary outcomes

  1. biochemically validated 7-day abstinence

    Time frame: 6 Months, 12 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2016
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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