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Clinical Trials/NCT04972916
NCT04972916
Completed
N/A

Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

Milton S. Hershey Medical Center1 site in 1 country12 target enrollmentJune 15, 2021
ConditionsTobacco Use

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tobacco Use
Sponsor
Milton S. Hershey Medical Center
Enrollment
12
Locations
1
Primary Endpoint
Participant recruitment efficiency and retention rate
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tongyao Fan

Principal Investigator

Milton S. Hershey Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Number of participants engaged in tobacco treatments(At the final assessment, 2 months after baseline)

Study Sites (1)

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