Intervention Study of Communication in Oncologist-Patient Encounters (COPE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00994578
First received: October 12, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The overall goal of this study is to improve communication between patients with advanced cancer and their oncologists. A web-based communication intervention will be delivered to patients to help them to express their negative emotions and elicit empathic responses from their oncologists.

The specific aims are to:

AIM 1: Develop a web-based intervention that trains patients with advanced cancer to express their emotional concerns to their oncologists and to request emotional support during clinical encounters.

AIM 2: Test whether this intervention can increase patient expression of emotional concerns and requests for emotional support, as well as improve patient affect by decreasing negative emotions.


Condition Intervention
Advanced Cancer
Behavioral: CHESS
Behavioral: COPE
Behavioral: CHESS/COPE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: The COPE Trial: Communication in Oncologist-Patient Encounters

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Patient expression of emotion [ Time Frame: Clinic Visits 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients randomized to the COPE only arm will have lower levels of negative affect and an increased number of requests for emotional support as compared to patients in the Internet only arm. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Patients randomized to the CHESS only arm will have lower levels of negative affect as compared to patients in the Internet only arm. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Patients randomized to the CHESS+COPE arm will have an increased number of expressions of emotional concerns and lower levels of negative affect as compared to patients in either the COPE only or CHESS only arms. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1310
Study Start Date: November 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Internet Only
Patients assigned to the internet only group will enter the initial CHESS portal which will take them to a window displaying a standard web search engine and common cancer information sites. We will monitor their internet usage via logins to the CHESS portal.
Experimental: CHESS
Participants in the CHESS arm will be given access to the University of Wisconsin CHESS website, modified specifically for this study. After being trained in usage of the site, they will use the available resources as desired without further input from the study team, except for technical support. The participant's usage of the site will be monitored.
Behavioral: CHESS
Patients randomized to the CHESS intervention will be trained to access the website. After being trained in usage of the site, they will use the available resources as desired without further input from the study team, except for technical support
Experimental: COPE
Participants in the COPE arm will receive training and access to the COPE patient intervention, an interactive web program based on Social Cognitive Theory that includes automated, tailored email reminders and encouragement prior to each visit, and access to the patient's audio-recorded conversations for review. The participant's usage of the site will be monitored.
Behavioral: COPE
Participants in the COPE arm will receive training and access to the COPE patient intervention, an interactive web program based on Social Cognitive Theory that includes automated, tailored email reminders and encouragement prior to each of two oncologists visits over a maximum of a 9 month period, and access to the patient's audio-recorded conversations for review.
Experimental: CHESS/COPE
Participants in the CHESS+COPE arm will receive training in, and access to, both components on the CHESS website, with the accompanying levels of support. The participant's usage of the site will be monitored.
Behavioral: CHESS/COPE
Participants in the CHESS/COPE arm will be given access to the University of Wisconsin CHESS modified specifically for this study. After being trained in usage of the site, they will use the available resources as desired and receive technical support. COPE arm will receive training and access to the COPE patient intervention an interactive web program based on Social Cognitive Theory that includes automated, tailored email reminders and encouragement prior to two oncologists visits over a maximum period of 9 months, and access to the patient's audio-recorded conversations for review.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. speak English;
  2. have a diagnosis of advanced cancer (Stage IV or however defined for that disease group), metastatic disease, or refractory or recurrent illness;
  3. have access to a telephone; and,
  4. have regular access to a computer with broadband Internet service and an email account.

Exclusion Criteria:

  1. incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer;
  2. hearing impaired or have a speech disorder;
  3. physically impaired in such a way that precludes the use of a computer;
  4. simply too sick to participate, and cannot realistically participate in the interview, as judged by the research assistant; or
  5. does not have another appointment with an enrolled oncologist within three months.
  6. has dial-up Internet service, or
  7. does not meet IES Score.

While only patient subjects with advanced cancer will be eligible for randomization into one of the study arms, healthy volunteers (providers and third parties) will be enrolled in the study, too. Patients will be recruited from the practices of participating oncologists; therefore, physicians will be enrolled prior to their patients. All medical, surgical and radiation oncology faculty and hematology/oncology fellows who see patients in the participating clinics will be eligible for the study. We also will enroll the mid-level providers (i.e., physician assistants and nurse practitioners) who work with many of these oncologists and any third party (friends, family members) who comes to clinic with the enrolled patient.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994578

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2582
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Tulsky, MD Duke University
Principal Investigator: Yael Schenker, MD University of Pittsburgh
Study Director: Kathryn Pollak, PhD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00994578     History of Changes
Other Study ID Numbers: Pro00013032 (2R01CA100387), 2R01CA100387-06A1
Study First Received: October 12, 2009
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014