Patient Navigation-based Tobacco Harm Reduction Program Among Cancer Patients

NCT04972916 | Completed

• 1 other identifier: STUDY00017696
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use

Keywords

cancer patients; tobacco harm reduction; patient navigation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants engaged in tobacco treatments

  At the final assessment, 2 months after baseline

Study Arms (1)

Patient Navigation-based Tobacco Harm Reduction Intervention

OTHER

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

Interventions

Patient navigation-based tobacco harm reduction intervention OTHER

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.

Patient Navigation-based Tobacco Harm Reduction Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tongyao Investigator, MPH

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 22, 2021
• Study Start: June 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

US (1)