Effective Communication for Preventing and Responding to Oncology Adverse Events

Cancer Clinical Trial

— CanComm  

Official title:

Effective Communication for Preventing and Responding to Oncology Adverse Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871948
• Other study ID #: 1184
• Secondary ID: P20CA137219
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: December 12, 2013
• Start date: October 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• "We Want 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Georgia	Atlanta	Georgia
United States	Group Health	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate differences in satisfaction with cancer care communication, using a summary score from patient surveys, between intervention and control groups.		8 months	No