Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

January 9, 2022 updated by: Tongyao Fan, Milton S. Hershey Medical Center
The purpose of this study is to examine the feasibility and preliminary efficacy of patient navigation to promote linkage to smoking cessation treatments in cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to conduct a 2-month 1-arm intervention study that will recruit up to 20 smoking cancer patients at Penn State Cancer Institute. All participants will receive a smoking cessation educational brochure and patient navigation intervention (in-person or by phone) delivered over two months. At the first intervention interview, the patient navigators will educate participants about the benefits of quitting, introduce smoking cessation resources, motivate participants to link with treatment, help participants attend smoking cessation treatments, and assess barriers that prevented them from being able to consider smoking cessation. The cessation treatment resources will be discussed include PennState Health Smoking Cessation Clinic, Pennsylvania Quitline, or visiting their primary care provider (PCP) to discuss cessation, prescription medications, and/or nicotine replacement therapy. A follow-up call will be made 1 month later to further assist and motivate to use tobacco treatment services, and assess interim tobacco treatment engagement outcome. At 2 months after baseline, the final questionnaire will be administered to assess participants' smoking behaviors, engagement in tobacco treatments, and satisfaction with the intervention.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: ≥ 18 years of age
  • Diagnosis of cancer
  • Current cigarette smoker (smoked cigarettes in last 30 days)
  • Be able to read and speak English

Exclusion Criteria:

  • Age: < 18 years of age
  • Unable to read and speak English
  • Actively using evidence-based smoking cessation treatments
  • Known decisional impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient Navigation-based Tobacco Harm Reduction Intervention
All participants will receive a smoking cessation educational brochure and patient navigation intervention delivered over 2 months.
Other: Patient navigation-based tobacco harm reduction intervention
At the first intervention interview, the patient navigators will educate participants about the benefits of quitting, introduce smoking cessation resources, motivate participants to link with treatment, help participants attend smoking cessation treatments, and assess barriers that prevented them from being able to consider smoking cessation. The cessation treatment resources will be discussed include PennState Health Smoking Cessation Clinic, Pennsylvania Quitline, or visiting their primary care provider (PCP) to discuss cessation, prescription medications, and/or nicotine replacement therapy. A follow-up call will be made 1 month later to further assist and motivate to use tobacco treatment services, and assess interim tobacco treatment engagement outcome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant recruitment efficiency and retention rate
Time Frame: From baseline to completion of final assessment, approximately 2 months
This outcome is measured by the ability to recruit and enroll 20 participants for the 2-month program, individual participant attendance in patient navigation intervention visits, and completion of final assessment.
From baseline to completion of final assessment, approximately 2 months
Acceptability of intervention will be measured by likert-scale questions assessing helpfulness and satisfaction with intervention sessions, feedback on the intervention sessions, and smoking perceptions and behaviors changes
Time Frame: At the final assessment, 2 months after baseline. The changes in smoking perceptions and behaviors will be compared between baseline and final assessments.
Acceptability will be measured by Likert-scale questions assessing helpfulness and satisfaction with patient navigation intervention sessions, feedback on the intervention sessions, and smoking perceptions and behaviors changes including perceptions of risk, nicotine dependence, stage of change.
At the final assessment, 2 months after baseline. The changes in smoking perceptions and behaviors will be compared between baseline and final assessments.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants engaged in tobacco treatments
Time Frame: At the final assessment, 2 months after baseline
Engagement is defined as completion at least one tobacco cessation counseling session OR use of at least one FDA-approved cessation medication for at least 1 day.
At the final assessment, 2 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Tongyao Investigator, MPH, Penn State College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00017696

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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