- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Oregon
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Portland, Oregon, Stati Uniti, 97239
- OHSU Knight Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Studi accessori
Undergo motivational interviewing training
Undergo medical chart review
Altri nomi:
Attend phone or in-person motivational interviewing coaching sessions
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in frequency of tobacco counsel
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: John Holland, OHSU Knight Cancer Institute
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00016428 (Altro identificatore: OHSU Knight Cancer Institute)
- NCI-2017-00576 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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