Ovarian NeoplasmsNCT02809339
Improving Quality of Care for Patients With Recurrent Ovarian Cancer
An observational study of Ovarian Neoplasms and Quality of Life, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Quality of Life
- What is being tested?
- Questionnaires
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Questionnaires
- Keywords
- Chemotherapy, ovarian cancer, Patient reported outcome, Quality of Care
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of disease symptom relief and its duration by systemic therapy measured by change in MOST questionnaires on PROs and response to therapy
Measured: 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 outcomes (6)
Change in patient reported disease symptoms top 3 due to systemic therapy on their top 3 of complaints
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: change measured before start of therapy, at week 9 and 18 and at time of progression or 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Nelleke Ottevanger, M.D. PhD, Principal investigator, Internist - Oncologist and Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809339
- Sponsor's protocol ID
- MOGYN24
- Status last verified
- Apr 2016
- First submitted
- 7 Mar 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care for Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02809339
- Acronym / sponsor ID
- MOGYN24
- Conditions
- Ovarian Neoplasms, Quality of Life
- Keywords
- Chemotherapy, ovarian cancer, Patient reported outcome, Quality of Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epithelial ovarian cancer | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires | Other | Epithelial ovarian cancer |
Primary outcome
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
6 secondary outcomes
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 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 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 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 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelleke Ottevanger, M.D. PhD principal investigator
Internist - Oncologist and Principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Quality of Life, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Rietveld, M.D. Msc. (+31 24 36 10353, mark.rietveld@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.