Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Patient navigation-based tobacco harm reduction intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient Navigation-based Tobacco Harm Reduction Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant recruitment efficiency and retention rate | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer patients, tobacco harm reduction, patient navigation