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

NCT07072312 | Completed

• 1 other identifier: 22-1011
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Tobacco Cessation; Patient Navigation

Outcome Measures

Primary Outcomes (4)

• Feasibility of Integrating Navigation into Tobacco Treatment Program

  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.

  Prior to first TTP visit - consented and enrolled

• Patient Acceptability of Navigation in Tobacco Treatment - Patient Recommendation

  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.

  One and six months post initial navigation intervention

• Provider Implementation of the Intervention -Fidelity to Protocol

  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.

  Baseline to 6 months

• Fidelity of Utilization of Navigation Intervention - Patient Participation

  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.

  Baseline to 6 months

Secondary Outcomes (1)

• 7-Day Point Prevalence

  Six months

Study Arms (1)

Patient Navigation

EXPERIMENTAL

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

Behavioral: Adjuvant Patient Navigation for Tobacco Treatment

Interventions

Adjuvant Patient Navigation for Tobacco Treatment 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.

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Temple University: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Linda Fleisher, PhD, MPH

  Temple Univeristy Health System - Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: July 18, 2025
• Study Start: November 10, 2022
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)