Feasibility, Acceptability and Fidelity of Integrating a Navigation Intervention Into Tobacco Treatment Program

NCT ID: NCT07072312

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-08-27

Brief Summary

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Patient Navigation is being included as part of a tobacco treatment program for cancer patients to help patients overcome barriers to quitting.

Detailed Description

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The primary objective of this prospective, interventional pilot study is to assess the feasibility, acceptability and fidelity of a navigation intervention embedded into the clinical Tobacco Treatment Program.

The investigators will employ a pre-post design with two cohorts (30 to the pre-intervention, and 90 to the intervention, respectively) to address the specific aims of the study.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The first 30 patients are enrolled to the pre-intervention group and receive standard of care to serve as a comparison group. The subsequent patients are enrolled to the single arm to receive the standard care and patient navigation intervention.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient Navigation

Participants receive patient navigation after their first and second tobacco treatment visits.

Group Type EXPERIMENTAL

Adjuvant Patient Navigation for Tobacco Treatment

Intervention Type BEHAVIORAL

Patients in the study meet with the Patient Navigator two weeks after their first tobacco treatment visit and again after their second visit with the Tobacco Treatment Provider. The Patient Navigator will discuss psychosocial and other cessation barriers. The Patient Navigator will connect the patients with appropriate resources to help overcome these barriers.

Interventions

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Adjuvant Patient Navigation for Tobacco Treatment

Patients in the study meet with the Patient Navigator two weeks after their first tobacco treatment visit and again after their second visit with the Tobacco Treatment Provider. The Patient Navigator will discuss psychosocial and other cessation barriers. The Patient Navigator will connect the patients with appropriate resources to help overcome these barriers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with a cancer diagnosis. Patients may be undergoing active therapy or may have completed treatment.
2. English speaking.
3. Age \> 18 years.
4. Active tobacco cigarette user, defined as having smoked a cigarette within the 30 days prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Linda Fleisher

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Fleisher, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Temple Univeristy Health System - Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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22-1011

Identifier Type: -

Identifier Source: org_study_id

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