Advanced CancerCOPENCT00994578
Intervention Study of Communication in Oncologist-Patient Encounters
A study testing CHESS, COPE and CHESS/COPE in people with Advanced Cancer, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- CHESS, COPE and CHESS/COPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Health System
Durham, North Carolina, 27705
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2582
About this study
Official title: The COPE Trial: Communication in Oncologist-Patient Encounters
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Advanced Cancer
- Being tested
- CHESS, COPE, CHESS/COPE
- Keywords
- Advanced cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHESSBehavioural
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
COPEBehavioural
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.
CHESS/COPEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: CHESS/COPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient expression of emotion
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startNov 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James A Tulsky, MD, Principal investigator, Duke UniversityYael Schenker, MD, Principal investigator, University of PittsburghKathryn Pollak, PhD, Study director, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994578
- Sponsor's protocol ID
- Pro00013032
- Other IDs
- 2R01CA100387-06A1
- Acronym
- COPE
- Status last verified
- Sep 2014
- First submitted
- 12 Oct 2009
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COPE Trial: Communication in Oncologist-Patient Encounters
- ClinicalTrials.gov ID
- NCT00994578
- Acronym / sponsor ID
- COPE / Pro00013032
- Conditions
- Advanced Cancer
- Keywords
- Advanced cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: CHESSParticipants 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. |
| COPE | Experimental | Behavioral: COPEParticipants 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. |
| CHESS/COPE | Experimental | Behavioral: CHESS/COPEParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHESSPatients 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 | Behavioural | CHESS |
| COPEParticipants 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. | Behavioural | COPE |
| CHESS/COPEParticipants 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. | Behavioural | CHESS/COPE |
Primary outcome
Patient expression of emotion
Time frame: Clinic Visits 2 and 3
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Tulsky, MD principal investigator
Duke University
Yael Schenker, MD principal investigator
University of Pittsburgh
Kathryn Pollak, PhD study director
Duke Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHESS, COPE and CHESS/COPE in people with Advanced Cancer, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient expression of emotion (time frame: Clinic Visits 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.