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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
Sponsor:
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
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
 (submitted: December 12, 2012)		 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).
Original Primary Outcome Measures
 (submitted: August 31, 2012)		 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).
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
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.
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 31, 2012)		 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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
  • 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
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date February 2021