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CompletedNCT01871948CanCommUpdated Dec 16, 2013

Effective Communication for Preventing and Responding to Oncology Adverse Events

An interventional study of "We Want to Know" campaign, Patient survey at 2 time points in Cancer, sponsored by University of Massachusetts, Worcester. Completed at 2 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-16.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cancer survivors
  • 21 to 80 years of age
  • Able to communicate in English
  • have adequate hearing
  • no cognitive impairments

Exclusion criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
500 participants (estimated)

Study arms

  • No intervention
    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.

  • Experimental
    "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.

    Other: "We Want to Know" campaign, Patient survey at 2 time points

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. Calculate differences in satisfaction with cancer care communication, using a summary score from patient surveys, between intervention and control groups.

    Time frame: 8 months

07

Study locations

2 sites
  • Kaiser Permanente Georgia
    Atlanta, Georgia 30305, United States
  • Group Health
    Seattle, Washington 98124, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01871948
Lead sponsor
University of Massachusetts, Worcester
Collaborators
National Cancer Institute (NCI)
Responsible party
Kathleen Mazor (Associate Professor of Medicine, University of Massachusetts, Worcester) — Principal investigator
First posted
Jun 7, 2013
Start date
Oct 2008
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Dec 16, 2013

Study contacts

Kathleen M Mazor, EdD
principal investigator · University of Massachusetts, Worcester
Thomas H Gallagher, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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