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Proactive Care Coordination for Cancer Survivors Who Smoke

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ClinicalTrials.gov Identifier: NCT02723656
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Online Referral NYS Quitline Behavioral: Tobacco cessation counseling and coordination of cessation medications Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 581 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48
Study Start Date : March 2016
Actual Primary Completion Date : September 29, 2018
Actual Study Completion Date : September 29, 2018

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Arm Intervention/treatment
Active Comparator: Proactive mailed care coordination Behavioral: Online Referral NYS Quitline
Care coordinator will make an online referral to the NYS Quitline.

Active Comparator: Proactive telephone care coordination. 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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. biochemically validated 7-day abstinence [ Time Frame: 6 Months, 12 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723656


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Paul Krebs, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02723656     History of Changes
Other Study ID Numbers: 15-01069
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by NYU Langone Health:
smoking
cancer
cancer registry
smoking cessation