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

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT07072312
• Lead Sponsor: Fox Chase Cancer Center

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.

Study Timeline

• Study Start: 2022-11-10
• Study First Submitted: 2024-03-01
• Primary Completion: 2024-08-27
• Study Completion: 2024-08-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Feasibility of Integrating Navigation into Tobacco Treatment Program	Prior to first TTP visit - consented and enrolled	The 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 Recommendation	One and six months post initial navigation intervention	The 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 Protocol	Baseline to 6 months	The 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 Participation	Baseline to 6 months	Number 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 Outcome Measures

Name	Time	Method
7-Day Point Prevalence	Six months	7-Day point prevalence of tobacco will be assessed at six month follow up.

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States