Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy

Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study

This pilot clinical trial studies how well provider training works in increasing patient tobacco cessation counseling and referrals for patients with cancer undergoing radiation therapy. Health care provider training in motivational interviewing techniques and utilizing tobacco cessation resources may help doctors understand how health care providers can effectively increase their confidence in talking to patients about tobacco cessation counseling.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Breast Carcinoma; Head and Neck Carcinoma; Lung Carcinoma; Prostate Carcinoma; Caregiver
• Intervention / Treatment: Other: Questionnaire Administration; Other: Communication Skills Training; Other: Medical Chart Review; Other: Tobacco Cessation Counseling

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if training providers on tobacco cessation resources increases the frequency of counseling and referrals at initial and follow-up consultations for cancer patients who use tobacco and are scheduled to receive radiation at Oregon Health and Science University (OHSU).

SECONDARY OBJECTIVES:

I. Increase provider frequency of tobacco use quantification and type. II. Increase frequency of provider assessment of tobacco cessation readiness in current users.

III. Increase frequency and types of tobacco cessation resources and medicines offered and utilized.

IV. Increase frequency and type of follow-up planned if referred to cessation resource.

OUTLINE:

MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.

PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.

PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MEDICAL CHART REVIEW
• Pre-intervention: 200 patient records between January 1, 2016 and December 31, 2016 are subject to review; the first 50 records with a diagnoses of each cancer type: head and neck, lung, prostate, or breast will be utilized for the review
• Post-intervention: 200 patient records receiving care beginning six months post training are subject to review; the first 50 records with a diagnoses of head and neck, lung, prostate, or breast will be utilized
• PROVIDER TRAINING
• OHSU Radiation Medicine department has agreed to participate as pilot department for this project; all active Radiation Medicine providers are requested to participate in the training; providers have the option to not participate
• TOBACCO CESSATION COACHING
• Patients who are at least 18 years of age
• Speak English
• Report tobacco use within the past 7 days
• Willing to consider quitting smoking
• Patients must be willing to meet four times in person or on the phone to discuss tobacco use
• Patients must be willing to be audio recorded during the sessions
• Patients who meet this criteria will be referred to OHSU Health Promotion Sports Medicine researcher, Carol DeFrancesco, to complete assessment using stages of change tobacco use readiness ruler and question set
• Patient smoking status will be documented in their electronic health record, per routine care

Exclusion Criteria:

• Vulnerable Populations

  • The following groups will be excluded from participation:

    • Children
    • Decisionally impaired adults
    • Prisoners
    • Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health Services Research (Chart review, training, coaching); MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training. PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions. PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

Other: Questionnaire Administration; Ancillary studies; Other: Communication Skills Training; Undergo motivational interviewing training; Other: Medical Chart Review; Undergo medical chart review; Other Names: Chart Review; Other: Tobacco Cessation Counseling; Attend phone or in-person motivational interviewing coaching sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of tobacco counsel	Will be compared between the cohort of pre and post intervention. Will be summarized using descriptive statistics and compared using chi-square test by tumor type.	Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review	Will be summarized using descriptive statistics and compared using chi-square test by tumor type.	Baseline up to 24 months
Change in frequency and types of tobacco cessation resources and medicines offered and utilized assessed by medical chart review	Will be tested using a chi-squared test. If any expected cell count in the contingency table is lower than 5, we will instead use Fisher's exact test.	Baseline up to 24 months
Change in frequency of provider assessment of tobacco cessation readiness in current users assessed by medical chart review	Will be summarized using descriptive statistics and compared using chi-square test by tumor type.	Baseline up to 24 months
Change in provider frequency of tobacco use quantification and type assessed by medical chart review	Will be summarized using descriptive statistics and compared using chi-square test by tumor type. Will be tested using Z tests of proportion.	Baseline up to 24 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: John Holland, OHSU Knight Cancer Institute

Publications and helpful links

General Publications

• Holland JM, Holland E, Chen Y, Brown SA. Smoking history and cessation discussions in cancer patients receiving definitive radiotherapy: Do we treat all patients equally? Tob Prev Cessat. 2020 May 22;6:31. doi: 10.18332/tpc/120308. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Breast Diseases; Prostatic Diseases; Breast Neoplasms; Prostatic Neoplasms; Carcinoma
• Other Study ID Numbers: STUDY00016428 (Other Identifier: OHSU Knight Cancer Institute); NCI-2017-00576 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No