Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02090582
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2014-03-04
Brief Title:
HOPE Helping Ovarian Cancer Patients Cope
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pilot Study on HOPE Helping Ovarian Cancer Patients Cope During Disease Recurrence
Status:
COMPLETED
Status Verified Date:
2020-05
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 purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration GO-PC intervention on patient quality of life
Detailed Description:
Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer All patient participants will complete two quality of life QOL questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks
Patients will be assigned to two arms randomly 1 usual care or 2 structured palliative care The primary endpoint is quality of life A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire
Patients will be assigned to two arms randomly 1 usual care or 2 structured palliative care The primary endpoint is quality of life A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire
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