Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00994578
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2009-10-12
Brief Title:
Intervention Study of Communication in Oncologist-Patient Encounters
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
The COPE Trial Communication in Oncologist-Patient Encounters
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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
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 hematologyoncology fellows who see patients in the participating clinics will be eligible for the study We will also enroll the mid-level providers ie 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 She 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 she 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 CHESSCOPE 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 eg 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
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 She 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 she 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 CHESSCOPE 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01CA100387-06A1 | NIH | None | httpsreporternihgovquickSearch2R01CA100387-06A1 |