Improving Quality of Care for Patients With Recurrent Ovarian Cancer

NCT02809339UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Radboud University Medical Center

Enrollment

360

Start Date

2016-07-01

Completion Date

2017-12-01

Study Type

OBSERVATIONAL

Official Title

Improving Quality of Care for Patients With Recurrent Ovarian Cancer

Interventions

Questionnaires

Conditions

Ovarian NeoplasmsQuality of Life

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

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