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

Feasibility, Acceptability and Fidelty of Integrating Navigation to Improve Adherence: Tobacco Treatment Program for Cancer Patients A Pragmatic Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07072312
Enrollment
93
Registered
2025-07-18
Start date
2022-11-10
Completion date
2024-08-27
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Tobacco Cessation, Patient Navigation

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALAdjuvant 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.

Sponsors

Temple University
CollaboratorOTHER
Fox Chase Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Integrating Navigation into Tobacco Treatment ProgramPrior to first TTP visit - consented and enrolledThe number of patients who enroll and consent to receiving the tobacco treatment program navigation intervention. Feasibility will be obtained if at least 60% consent and enroll.
Patient Acceptability of Navigation in Tobacco Treatment - Patient RecommendationOne and six months post initial navigation interventionThe number of patients who state they would likely or highly likely to recommend the service to other cancer patients. Acceptability will obtained if 70% of patients likely recommend the service.
Provider Implementation of the Intervention -Fidelity to ProtocolBaseline to 6 monthsThe number of patients who receive the two primary components of the navigation intervention, assessing tobacco cessation barriers and psychosocial barriers. Fidelity will be achieved if 80% of cases include both elements measured through a review of the navigation case management system.
Fidelity of Utilization of Navigation Intervention - Patient ParticipationBaseline to 6 monthsNumber of patients who had at least 2 navigation encounters. Fidelity will be achieved if 80% of patients have a minimum of 2 navigation encounters through the navigation case management review.

Secondary

MeasureTime frameDescription
7-Day Point PrevalenceSix months7-Day point prevalence of tobacco will be assessed at six month follow up.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026