Clinical trial NCT04972916: Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients
Official title: Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: cancer patients
tobacco harm reduction
patient navigation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Participant recruitment efficiency and retention rate
timeFrame: From baseline to completion of final assessment, approximately 2 months
measure: 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
timeFrame: At the final assessment, 2 months after baseline. The changes in smoking perceptions and behaviors will be compared between baseline and final assessments.
Secondary outcomes:
measure: Number of participants engaged in tobacco treatments
timeFrame: At the final assessment, 2 months after baseline
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Tongyao Investigator, MPH
role: PRINCIPAL_INVESTIGATOR
References: