NCT03135782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

April 26, 2017

Last Update Submit

March 3, 2021

Conditions

Breast CarcinomaCaregiverHead and Neck CarcinomaLung CarcinomaProstate CarcinomaTobacco Use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review

    Baseline up to 24 months

  • Change in frequency and types of tobacco cessation resources and medicines offered and utilized assessed by medical chart review

    Baseline up to 24 months

  • Change in frequency of provider assessment of tobacco cessation readiness in current users assessed by medical chart review

    Baseline up to 24 months

  • Change in provider frequency of tobacco use quantification and type assessed by medical chart review

    Baseline up to 24 months

Study Arms (1)

Health Services Research (Chart review, training, coaching)

EXPERIMENTAL

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: Communication Skills TrainingOther: Medical Chart ReviewOther: Questionnaire AdministrationOther: Tobacco Cessation Counseling

Interventions

Communication Skills TrainingOTHER

Undergo motivational interviewing training

Health Services Research (Chart review, training, coaching)
Medical Chart ReviewOTHER

Undergo medical chart review

Also known as: Chart Review
Health Services Research (Chart review, training, coaching)
Questionnaire AdministrationOTHER

Ancillary studies

Health Services Research (Chart review, training, coaching)
Tobacco Cessation CounselingOTHER

Attend phone or in-person motivational interviewing coaching sessions

Health Services Research (Chart review, training, coaching)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Vulnerable Populations
  • The following groups will be excluded from participation:
  • Children
  • Decisionally impaired adults
  • Prisoners
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related 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.

    PMID: 32760866BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsProstatic NeoplasmsTobacco Use

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • John Holland

    OHSU Knight Cancer Institute

    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
Associate Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

August 1, 2017

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

US(1)