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 we intend (1) to…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the velocity of disease symptom relief and its duration by systemic therapy
measured by questionnaires on PROs and response to therapy. Primary endpoints:
changes in outcomes on QoL and symptoms due to disease and treatment.
Secondary outcome
Petient reported disease symptoms top 3, response to therapy as measured by
CA-125 and radiology, distress, emotional wellbeing, Empowerment and change in
patient reported needs.
Background 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 we intend to augment
knowledge by PROs of different chemotherapy schedules for recurrent ovarian
cancer in order to improve shared decision making with the physician.
Study 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 we
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
prospective exploratory study
Study burden and risks
participation in this study imposes no additional risks to patients, except the
completion of questionnaires (<24months, 10 times one questionnaire that takes
20 minutes of the patients' time)
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57147.091.16 |