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Improving Quality of Care for Patients With Recurrent Ovarian Cancer

NCT02809339 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2016-06-22

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms
  • Quality of Life

Interventions

OTHER

Questionnaires

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Nelleke Ottevanger, M.D. PhD · Internist - Oncologist and Principal investigator

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809339 on ClinicalTrials.gov