Improving Quality of Care for Patients With Recurrent Ovarian Cancer

Quality of Life Clinical Trial

Official title:

Improving Quality of Care for Patients With Recurrent Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02809339
• Other study ID #: MOGYN24
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: June 18, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Radboud University
• Contact: Mark Rietveld, M.D. Msc.
• Phone: +31 24 36 10353
• Email: mark.rietveld[@]radboudumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Quality of Life

Intervention

Other:
• Questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	PharmaMar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity of disease symptom relief and its duration by systemic therapy measured by change in MOST questionnaires on PROs and response to therapy		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	No
Secondary	Change in patient reported disease symptoms top 3 due to systemic therapy on their top 3 of complaints		change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year	No
Secondary	Change in top 3 complaints due to chemotherapy		change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year	No
Secondary	Change in patient reported psychosocial wellbeing		Change measured by HADS questionnaires before start of therapy, at week 9 and 18 and at time of progression or 1 year	No
Secondary	Change in patient reported empowerment		Change measured by NEV questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year	No
Secondary	Change in patient reported needs		Change measured on CASUN questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year	No
Secondary	Response to therapy by CA-125 (according to GCIG criteria and radiology by RECIST 1.1 criteria)		change measured before start of therapy, at week 9 and 18 and at time of progression or 1 year	No