- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01871948
Effective Communication for Preventing and Responding to Oncology Adverse Events (CanComm)
12 december 2013 uppdaterad av: Kathleen Mazor, University of Massachusetts, Worcester
Cancer patients often experience problems in their care, many of which are caused by communication breakdowns.
Some communication breakdowns lead to adverse events and even harmful errors.
Deficiencies in provider-patient communication can compound patients' distress, lower the quality of care, and disrupt patient-provider relationships.
There is little research on patients' and providers' experiences of the communication breakdowns that precipitate adverse events and errors, or on effective responses to these events.
Because of this, cancer providers are unsure how to communicate with patients in these difficult situations.
The goal of the proposed study is to improve patient-centered communication around adverse events and errors in cancer care.
Our specific aims are: 1) To describe patients' experiences with communication around adverse events and errors in cancer care, 2) To describe providers' experiences and practices with communication around adverse events and errors in cancer care, 3) To develop practical recommendations, provider training materials and patient educational materials for improving communication around adverse events and errors in cancer care, 4) To disseminate the recommendations and materials through three health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and impact of the materials.
The investigators will first conduct interviews with breast and colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester, Massachusetts).
The interviews will focus on instances where patients believe that better communication might have prevented an adverse event or error, or mitigated the event's impact.
Next the investigators will conduct focus groups to understand providers' attitudes and experiences with these communication dilemmas, and use simulations to describe providers' communication practices.
Finally, the investigators will interview health plan leaders to identify the systems factors that influence communication with patients around adverse events and errors.
These perspectives will be synthesized to create patient and provider educational material for improving communication.
Three advisory panels: a Patient Advisory Panel, a Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health plans) will help create and disseminate these educational interventions.
Dissemination will occur at the three core clinical sites.
The investigators use patient and provider surveys to evaluate the educational materials' impact.
This evaluation will provide the evidence-base to refine the study products before widespread dissemination throughout the CRN and beyond.
The project will have the advantage of the CRN infrastructure, the CRN Clinical Communication Research Center, and is led by nationally recognized communication researchers.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
500
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Georgia
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Atlanta, Georgia, Förenta staterna, 30305
- Kaiser Permanente Georgia
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Washington
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Seattle, Washington, Förenta staterna, 98124
- Group Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Cancer survivors
- 21 to 80 years of age
- Able to communicate in English
- have adequate hearing
- no cognitive impairments
Exclusion Criteria:
-Any non-melanoma skin cancer, Breast cancer in situ, Cervical intraepithelial neoplasia (CIN): types I, II, III, Stage I colon cancer, Stage IV cancer, Recurrent cancer or second primary
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Patient survey at 2 points in time
Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
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Experimentell: "WeWant to Know" campaign, patient survey at 2 time points
Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.
|
Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Calculate differences in satisfaction with cancer care communication, using a summary score from patient surveys, between intervention and control groups.
Tidsram: 8 months
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8 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Kathleen M Mazor, EdD, University of Massachusetts, Worcester
- Huvudutredare: Thomas H Gallagher, MD, University of Washington
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2008
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
22 maj 2013
Först inskickad som uppfyllde QC-kriterierna
4 juni 2013
Första postat (Uppskatta)
7 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 december 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 december 2013
Senast verifierad
1 december 2013
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1184
- P20CA137219 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .