Skip to content

Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04972916
Enrollment
12
Registered
2021-07-22
Start date
2021-06-15
Completion date
2021-12-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

cancer patients, tobacco harm reduction, patient navigation

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.

Interventions

OTHERPatient 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.

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant recruitment efficiency and retention rateFrom baseline to completion of final assessment, approximately 2 monthsThis 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 changesAt 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

MeasureTime frameDescription
Number of participants engaged in tobacco treatmentsAt the final assessment, 2 months after baselineEngagement 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026