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

Primary Purpose

Breast Carcinoma, Caregiver, Head and Neck Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication Skills Training
Medical Chart Review
Questionnaire Administration
Tobacco Cessation Counseling
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health Services Research (Chart review, training, coaching)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 26, 2017
Last Updated
March 3, 2021
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03135782
Brief Title
Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy
Official Title
Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Caregiver, Head and Neck Carcinoma, Lung Carcinoma, Prostate Carcinoma, Tobacco Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Services Research (Chart review, training, coaching)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Communication Skills Training
Intervention Description
Undergo motivational interviewing training
Intervention Type
Other
Intervention Name(s)
Medical Chart Review
Other Intervention Name(s)
Chart Review
Intervention Description
Undergo medical chart review
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Tobacco Cessation Counseling
Intervention Description
Attend phone or in-person motivational interviewing coaching sessions
Primary Outcome Measure Information:
Title
Change in frequency of tobacco counsel
Description
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.
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review
Description
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
Time Frame
Baseline up to 24 months
Title
Change in frequency and types of tobacco cessation resources and medicines offered and utilized assessed by medical chart review
Description
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.
Time Frame
Baseline up to 24 months
Title
Change in frequency of provider assessment of tobacco cessation readiness in current users assessed by medical chart review
Description
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
Time Frame
Baseline up to 24 months
Title
Change in provider frequency of tobacco use quantification and type assessed by medical chart review
Description
Will be summarized using descriptive statistics and compared using chi-square test by tumor type. Will be tested using Z tests of proportion.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Holland
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32760866
Citation
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.
Results Reference
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Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy

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