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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03135782
Other study ID # STUDY00016428
Secondary ID NCI-2017-00576ST
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date September 23, 2020

Study information

Verified date March 2021
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date September 23, 2020
Est. primary completion date September 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States OHSU Knight Cancer Institute Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
OHSU Knight Cancer Institute Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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