Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01866228
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2013-04-16
Brief Title:
Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Impact of Treatment Consultation Recordings on Cancer Patient Outcomes A Prospective Parallel Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
The time period from diagnosis through to the end of treatment is challenging for patients Patients need information assistance with decision making and emotional and social support to help cope with their diagnosis and treatment The first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn for the first time their treatment options and likelihood of being cured This anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation The main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor The investigators will include newly diagnosed patients from cancer centres in Winnipeg and Calgary The types of cancer that will be included in this study are brain and neuroendocrine Patients with these types of cancer are more likely to have confused thinking and therefore may have the most to gain from receiving their consultation recordings The study will include 244 patients and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not Patients will receive their recording immediately after their consultation and will be able to listen to the recording at any time either alone or with family and friends To figure out whether the consultation recording provides patients with benefits the investigators will administer some questionnaires to patients at 1 week after the consultation and again at 3 and 6 months after the consultation These questionnaires will assess the following patient outcomes i anxiety and depression ii perception of being informed about the disease and treatment iii satisfaction with cancer care iv satisfaction with the doctor and v the extent to which patients are satisfied with their degree of involvement in treatment decision making The investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording
Detailed Description:
None
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 |
|---|---|---|---|
| 126049 | OTHER_GRANT | Canadian Institutes of Health Research126049 | None |