Breast CarcinomaNCT03135782
Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy
A study testing Communication Skills Training, Medical Chart Review and Questionnaire Administration in people with Breast Carcinoma and Caregiver, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Caregiver, Head and Neck Carcinoma
- What is being tested?
- Communication Skills Training, Medical Chart Review and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Vulnerable Populations
- The following groups will be excluded from participation:
- Children
- Decisionally impaired adults
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Carcinoma, Caregiver, Head and Neck Carcinoma, Lung Carcinoma, Prostate Carcinoma, Tobacco Use
- Being tested
- Communication Skills Training, Medical Chart Review, Questionnaire Administration, Tobacco Cessation Counseling
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Skills TrainingOther
Undergo motivational interviewing training
Medical Chart ReviewOther
Also called Chart Review
Undergo medical chart review
Questionnaire AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Attend phone or in-person motivational interviewing coaching sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Communication Skills Training; Other: Medical Chart Review; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Aug 2017
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, John Holland, OHSU Knight Cancer Institute
- Investigators
- John Holland, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135782
- Sponsor's protocol ID
- STUDY00016428
- Other IDs
- NCI-2017-00576, STUDY00016428
- Status last verified
- Mar 2021
- First submitted
- 26 Apr 2017
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32760866
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT03135782
- Acronym / sponsor ID
- STUDY00016428
- Conditions
- Breast Carcinoma, Caregiver, Head and Neck Carcinoma, Lung Carcinoma, Prostate Carcinoma, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (Chart review, training, coaching) | Experimental | Other: Communication Skills Training, Other: Medical Chart Review, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingMEDICAL 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- Vulnerable Populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Skills TrainingUndergo motivational interviewing training | Other | Health Services Research (Chart review, training, coaching) |
| Medical Chart ReviewAlso: Chart ReviewUndergo medical chart review | Other | Health Services Research (Chart review, training, coaching) |
| Questionnaire AdministrationAncillary studies | Other | Health Services Research (Chart review, training, coaching) |
| Tobacco Cessation CounselingAttend phone or in-person motivational interviewing coaching sessions | Other | Health Services Research (Chart review, training, coaching) |
Primary outcome
Change in frequency of tobacco counsel
Time frame: Baseline up to 24 months
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.
4 secondary outcomes
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review
Time frame: Baseline up to 24 months
Change in frequency and types of tobacco cessation resources and medicines offered and utilized assessed by medical chart review
Time frame: Baseline up to 24 months
Change in frequency of provider assessment of tobacco cessation readiness in current users assessed by medical chart review
Time frame: Baseline up to 24 months
Change in provider frequency of tobacco use quantification and type assessed by medical chart review
Time frame: Baseline up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 32760866Holland 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.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Holland principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Skills Training, Medical Chart Review and Questionnaire Administration in people with Breast Carcinoma and Caregiver, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of tobacco counsel (time frame: Baseline up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.