Intervention Study of Communication in Oncologist-Patient Encounters

NCT00994578 | Completed

• 2 other identifiers: Pro000130322R01CA100387-06A1
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Advanced cancer

Outcome Measures

Primary Outcomes (1)

• Patient expression of emotion

  Clinic Visits 2 and 3

Secondary Outcomes (3)

• 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.

  9 months

• Patients randomized to the CHESS only arm will have lower levels of negative affect as compared to patients in the Internet only arm.

  9 months

• 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.

  9 months

Study Arms (4)

Internet Only

NO INTERVENTION

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.

CHESS

EXPERIMENTAL

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

COPE

EXPERIMENTAL

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

CHESS/COPE

EXPERIMENTAL

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

Interventions

CHESS BEHAVIORAL

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

CHESS

COPE BEHAVIORAL

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.

COPE

CHESS/COPE BEHAVIORAL

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.

CHESS/COPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Study Officials

• James A Tulsky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Yael Schenker, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kathryn Pollak, PhD

  Duke Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: November 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (2)