- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03135782
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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- OHSU Knight Cancer Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hjelpestudier
Undergo motivational interviewing training
Undergo medical chart review
Andre navn:
Attend phone or in-person motivational interviewing coaching sessions
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in frequency of tobacco counsel
Tidsramme: 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.
|
Baseline up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review
Tidsramme: Baseline up to 24 months
|
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
Tidsramme: Baseline up to 24 months
|
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
Tidsramme: Baseline up to 24 months
|
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
Tidsramme: Baseline up to 24 months
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: John Holland, OHSU Knight Cancer Institute
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00016428 (Annen identifikator: OHSU Knight Cancer Institute)
- NCI-2017-00576 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
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