Viewing Study NCT02809339



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Last Modification Date: 2024-10-26 @ 12:04 PM
Study NCT ID: NCT02809339
Status: UNKNOWN
Last Update Posted: 2016-06-22
First Post: 2016-03-07

Brief Title: Improving Quality of Care for Patients With Recurrent Ovarian Cancer
Sponsor: Radboud University Medical Center
Organization: Radboud University Medical Center

Study Overview

Official Title: Improving Quality of Care for Patients With Recurrent Ovarian Cancer
Status: UNKNOWN
Status Verified Date: 2016-04
Last Known Status: NOT_YET_RECRUITING
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: Ovarian cancer is a major cause of cancer related death among women The disease is usually advanced at diagnosis because specialist referral is delayed due to vague nature of presenting symptoms Primary treatment is successful but most patients experience recurrence Complaints due to disease and therapy overlap Furthermore treatment schedules are similar in response rate and survival rates Toxicity of therapy as scored by the physician is best documented but varies depending on type of chemotherapy Moreover most knowledge is acquired in clinical trials and not in daily practice Patient reported outcome PROs concerning effects on symptoms velocity of relief and quality of life QoL by the different regimens is sparce Also it is unknown which symptoms are best relieved Most trials take into account progression or survival as primary endpoint but not often symptom relief which is especially important for patients with recurrent disease without no chance of cure anymore Knowledge on rating of problems and needs of patients with recurrent ovarian cancer ROC to support them in the course of their disease is needed to come to an evidence based and patient centered treatment of choice together with the patient Physicians most frequently use the Common Toxicity Criteria CTC scale for grading of side effects of treatment but discrepancies with patient experiences is high Routine collection of PROs may therefore improve patient expectations and management In this project the investigators intend to augment knowledge by PROs of different chemotherapy schedules for recurrent ovarian cancer in order to improve shared decision making with the physician

Objective primary objective of this project is to explore the relief of symptoms due to ROC the speed with which this occurs by different chemotherapy schedules and development of complaints due to the regimen of chemotherapy Secondary the investigators intend 1 to assess preferential symptom relief by patients 2 to correlate toxicity and symptoms of disease to tumor assessed response to chemotherapy and 3 to correlate symptom relief by psychosocial context
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