Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care
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ClinicalTrials.gov Identifier: NCT01678118 |
Recruitment Status :
Active, not recruiting
First Posted : September 3, 2012
Last Update Posted : February 6, 2020
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Condition or disease | Intervention/treatment |
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Minority Smokers | Behavioral: Patient Navigator |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care |
Actual Study Start Date : | April 2011 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | April 2021 |

Group/Cohort | Intervention/treatment |
---|---|
minority smokers
A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.
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Behavioral: Patient Navigator
The pt navigator will phone (email, text, or other preferred method of contact) pts prior to the date of previously set individual goals (e.g. going to an appt, getting their cessation medications filled, etc) as a reminder & to discuss barriers such as finances, transportation or ambivalent motivation. In this manner, pts receive navigation services tailored to their individual needs & barriers. Once pts are connected with a cessation service (defined as either using cessation medication or at least 1 contact with a Quitline or community-based cessation counselor)or provider-prescribed cessation medication usage, continues the navigation intervention will be considered complete. W/I the 3 month engagement period, pts will receive up to 6 contacts from the Pt Navigator following referral from primary care provider. Consistent with recommended pt navigation practice, the navigator will provide feedback to primary care provider regarding cessation services that the pts are receiving. |
- patient navigation (TPN) feasibility [ Time Frame: 1 year ]To evaluate the study's potential in terms of its reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of the intervention, tobacco-dependent patients will be asked to complete an intake interview and a telephone follow-up interview (at 3 to 6 months post-intervention).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age ≥ 18 years
- Self-reported current daily smoker, as verified with a portable alveolar carbon monoxide (CO) analyzer (24 hour point prevalence); CO levels ≥ 8 ppm.
- English and/or Spanish-speaking
- Referred to the navigation program by their primary care clinician
- At baseline, participants report at least thinking about quitting (i.e., Contemplation or Preparation stages of readiness to quit).
Exclusion Criteria:
- Serious, untreated psychiatric illness (e.g., schizophrenia,) or active substance abuse likely to preclude adherence to the protocol

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): NCT01678118
United States, New York | |
Heritage Health Center | |
New York, New York, United States, 10031 | |
Ralph Lauren Center for Cancer Care and Prevention | |
New York, New York, United States |
Principal Investigator: | Jamie Ostroff, PhD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01678118 |
Other Study ID Numbers: |
11-028 |
First Posted: | September 3, 2012 Key Record Dates |
Last Update Posted: | February 6, 2020 |
Last Verified: | February 2020 |
Patient Navigation Tobacco dependent smoking Cessation 11-028 |