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The COPE Trial: Communication in Oncologist-Patient Encounters


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Advanced Cancer

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Trial Information

The COPE Trial: Communication in Oncologist-Patient Encounters


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 will also enroll the mid-level providers (i.e.,
physician assistants and nurse practitioners) who work with many of these oncologists and
any third party who comes to clinic with the enrolled patient.

Biweekly, we will present participating physicians with a list of potentially eligible
patients (those with advanced disease) and ask them to identify those who should not be
approached about study participation. Reasons to not approach include dementia or
inappropriate disease staging. Identified patients will receive a letter from their
treating oncologist inviting them to participate in the study about oncologist-patient
communication. Patients who do not wish to be contacted about the study may call a
toll-free number to opt out. If patients do not respond, a research assistant will contact
them by telephone several days prior to their clinic visit, explain the study in detail, and
obtain verbal consent to conduct a phone screener and baseline interview. It is necessary
to conduct the screener and baseline survey prior to obtaining written consent so that staff
may determine eligibility and then initiate study procedures at the upcoming clinic visit,
if appropriate.

The baseline survey includes demographic information and several brief scales. Included in
these is the Impact of Events Scale (IES) to determine level of distress, as the COPE study
is interested in the subset of patients who are experiencing emotional difficulty with their
cancer and may be amenable to support in this domain from their provider. The IES is scored
from 0-44, with anything over 8 signifying at least mild levels of distress. Patients who
score 10 or below will be excluded from the study. After completing the survey measures,
arrangements will be made to meet patients in the clinic before their upcoming visit.

The research assistant will meet the patients in clinic, immediately prior to their next
visit, and obtain written informed consent. After engaging in the informed consent process,
the research assistant will place the audio recorder in the exam room, turn it on before the
oncologist enters the room, exit the room, and then turn off the recorder at the end of the
visit. S/he will not be present in the exam room during the visit. Subjects will complete
a survey immediately after the visit to assess affect and quality of communication.
Immediately after the visit, physicians will complete a very brief questionnaire to assess
their perception of the subjects' distress and whether s/he talked about their distress.

Once research assistants determine that participating patients have an appointment with the
same oncologist within 3 months, they will randomly assign subjects to one of four study
arms (Control, CHESS, COPE, or CHESS+COPE), stratified by site and gender. Research
assistants, equipped with laptop computers, will then introduce subjects to the
intervention. For subjects in the Control arm, research assistants will use the
intervention portal to review general Internet search tools (e.g., google). For subjects in
the three intervention arms, research assistants will demonstrate the appropriately modified
intervention website and ensure subjects' abilities to use it. Subjects will be provided
written materials on the use of the website, and instructions will also be sent shortly
afterward by email. The research assistant will call subjects within 7-14 days by phone and
administer a 1-week follow-up survey to assess affect. This process will be repeated until
staff record up to three clinic visits with the patient subject.

Staff will email and call patient subjects between clinic visits to remind them how to
access the intervention website and answer technical questions. Also, research assistants
will remind participants that a member of the study team will meet with them at their
upcoming oncology appointments.

In the last post-visit call with patient subjects, staff will re-administer the IES. Once
patients complete 3 audio-recorded visits, post-visits, and one-week follow-up interviews,
study participation will be complete.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Outcome Measure:

Patient expression of emotion

Outcome Time Frame:

Clinic Visits 2 and 3

Safety Issue:

No

Principal Investigator

James A Tulsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00013032 (2R01CA100387)

NCT ID:

NCT00994578

Start Date:

November 2010

Completion Date:

April 2014

Related Keywords:

  • Advanced Cancer
  • Advanced cancer
  • Neoplasms

Name

Location

University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Duke University Health SystemDurham, North Carolina  27705