Improving Quality of Care for Patients With Recurrent Ovarian Cancer

NCT ID: NCT02809339

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Ovarian Neoplasms; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Epithelial ovarian cancer

Questionnaires

Intervention Type: OTHER

Interventions

Questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with recurrent EOC or tubal carcinoma or peritoneal carcinoma;
• Histologically and/or cytologically proven epithelial ovarian cancer (including carcinosarcoma of the ovaries)
• Measurable or evaluable disease confirmed by radiological imaging OR ca 125
• ECOG ≤2
• Estimated life expectancy ≥12 weeks
• Patients must be accessible for treatment and follow-up
• Fit to receive chemotherapy

Exclusion Criteria

• Patients with benign ovarian cancer;
• Patients with non-epithelial cancer;
• Bowel obstruction, sub-occlusive disease or presence of symptomatic brain metastases;
• Patients with other malignancy occurring within 5 years before enrollment
• Patients with impaired cognitive functioning or analphabetic patients
• Patients with an inability to fill in surveys digitally

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelleke Ottevanger, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Internist - Oncologist and Principal investigator

Central Contacts

Mark Rietveld, M.D. Msc.

Role: CONTACT

mark.rietveld@radboudumc.nl

+31 24 36 10353

Other Identifiers

MOGYN24

Identifier Type: -

Identifier Source: org_study_id