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Completed

NCT Number: NCT07072312

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

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

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Integrating Navigation into Tobacco Treatment Program

    Time frame: 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.

  2. Patient Acceptability of Navigation in Tobacco Treatment - Patient Recommendation

    Time frame: 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.

  3. Provider Implementation of the Intervention -Fidelity to Protocol

    Time frame: 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.

  4. Fidelity of Utilization of Navigation Intervention - Patient Participation

    Time frame: 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 outcomes

  1. 7-Day Point Prevalence

    Time frame: Six months

    7-Day point prevalence of tobacco will be assessed at six month follow up.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Temple University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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