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 8, 2021
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Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
Sophie Davis School of Biomedical Education at The City College of New York
NYU Langone Health
Ralph Lauren Center for Cancer Care and Prevention
Heritage Health Center, New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | ||||
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First Submitted Date | August 30, 2012 | |||
First Posted Date | September 3, 2012 | |||
Last Update Posted Date | February 8, 2021 | |||
Actual Study Start Date | April 2011 | |||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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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Original Primary Outcome Measures |
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 months post-intervention).
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Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care | |||
Official Title | Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care | |||
Brief Summary | Patient navigators have been shown to assist people seeking cancer screening and other medical services. The purpose of this study is to see whether a patient navigator can link smokers to available community resources shown to help smokers quit smoking. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Participants will also be recruited from Heritage Health Center, located at 1727 Amsterdam Ave, which serves a large proportion to low income, minority patients in Harlem, New York. Also, from the Ralph Lauren Center for Cancer Care and Cancer Prevention (RLCCCP), a community based Center for the prevention, diagnosis, and treatment of cancer located at 1919 Madison Avenue. | |||
Condition | Minority Smokers | |||
Intervention | 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.
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Study Groups/Cohorts | minority smokers
A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.
Intervention: Behavioral: Patient Navigator
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
100 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | April 2022 | |||
Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01678118 | |||
Other Study ID Numbers | 11-028 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor | Memorial Sloan Kettering Cancer Center | |||
Collaborators |
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Investigators |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | February 2021 |