Improving Quality of Care for Patients With Recurrent Ovarian Cancer

June 18, 2016 updated by: Radboud University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients with recurrent epithelial ovarian cancer (EOC), tubal carcinoma or peritoneal carcinoma with measurable disease by radiology or tumor-marker and in adequate physical condition (ECOG≤2) to receive chemotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epithelial ovarian cancer
Other: Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Velocity of disease symptom relief and its duration by systemic therapy measured by change in MOST questionnaires on PROs and response to therapy
Time Frame: Change in MOST questionnaires as measured before start of therapy, at week 3, 6, 9 and 18 and and there after every 3 months until progression or 1 year
Change in MOST questionnaires as measured before start of therapy, at week 3, 6, 9 and 18 and and there after every 3 months until progression or 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in patient reported disease symptoms top 3 due to systemic therapy on their top 3 of complaints
Time Frame: change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change in top 3 complaints due to chemotherapy
Time Frame: change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change in patient reported psychosocial wellbeing
Time Frame: Change measured by HADS questionnaires before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change measured by HADS questionnaires before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change in patient reported empowerment
Time Frame: Change measured by NEV questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change measured by NEV questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change in patient reported needs
Time Frame: Change measured on CASUN questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Change measured on CASUN questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year
Response to therapy by CA-125 (according to GCIG criteria and radiology by RECIST 1.1 criteria)
Time Frame: change measured before start of therapy, at week 9 and 18 and at time of progression or 1 year
change measured before start of therapy, at week 9 and 18 and at time of progression or 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

PharmaMar

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

June 18, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOGYN24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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