|- candidate number||28415|
|- NTR Number||NTR6923|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2017|
|- Secondary IDs||NL62356.031.17 M17GSC |
|- Public Title||Geriatric screening in the treatment of elderly patients with ovarian carcinoma.|
|- Scientific Title||Geriatric screening in the treatment of elderly patients with ovarian carcinoma.|
|- hypothesis||Incorporation of geriatric screening tests into work-up for ovarian cancer therapy might improve completion of treatment in this population and prevent overtreatment of frail elderly patients. |
|- Healt Condition(s) or Problem(s) studied||Ovarian cancer, Ovary cancer|
|- Inclusion criteria||- A woman newly diagnosed with ovarian cancer FIGO stage II, III or IV aged 70 years or older|
- Able to complete a Dutch questionnaire
- Written and signed informed consent
|- Exclusion criteria||- Not being able to read or write Dutch, as they are not able to complete a Dutch questionnaire|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-aug-2017|
|- planned closingdate||15-aug-2021|
|- Target number of participants||320|
|- Interventions||This study is a pragmatic, cluster randomized controlled trial. Twenty hospitals will be randomized to either 'geriatric screening care' or 'care as usual'. |
In 'geriatric screening care', two geriatric screening tests will be performed during intake (G8-questionnaire and TUG). When determined unfit, patients are referred to a geriatrician for geriatric assessment and treatment advise. This group will be compared to 'care as usual' in which the decision to start, adapt or omit standard treatment will be made on information from usual history taking and physical examination.
|- Primary outcome||Primary endpoints include the percentage of started and completed therapies (standard as well as adapted) in 'geriatric screening care' and 'care as usual' and the difference in percentage in completed treatment in both groups.|
|- Secondary outcome||Secondary endpoints include health related quality of life; toxicity of treatment; progression free- and overall survival and cost-effectiveness in terms of incremental costs per quality adjusted life year from a societal perspective.|
|- Timepoints||- T=0: baseline characteristics|
- T=0, 6, 12 and 24 months after diagnosis: Quality of life and resource use (EORTC-C30, EORTC-OV28, EuroQol-5D-5L, abbreviated version of the iMCQ)
- T=24 months after diagnosis: survival, percentage started and completed treatment.
All other data related to the trial will be collected during follow-up.
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES|| N.J. Soolingen, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.W. Trum|
|- Sponsor/Initiator ||NKI-AVL|
(Source(s) of Monetary or Material Support)
|- Brief summary||Introduction: Advanced stage ovarian cancer is treated with combination chemotherapy and cytoreductive surgery. However, 40% of ovarian cancer patients is over 70 years of age and in many elderly patients treatment is withheld or stopped prematurely due to frailty and/or toxicity. It remains difficult to differentiate patients who are fit for standard treatment from patients who may need an adjusted treatment. The use of geriatric screening tests might improve identification of elderly patients who need further geriatric evaluation to improve tailored therapy of frail older patients.|
Aim: To increase the percentage of elderly patients with ovarian cancer who complete standard or adapted therapy by using geriatric screening prior to start of therapy.
Study population: Patients aged 70 years and older who are newly diagnosed with ovarian cancer FIGO-stage II - IV.
Methods: This study is a pragmatic, cluster randomized controlled trial in 20 hospitals in the Netherlands. Patients with newly diagnosed ovarian cancer are included prior to start of treatment with a follow-up of 24 months. Hospitals will be randomized to either geriatric screening care or care as usual. In geriatric screening care, two geriatric screening tests (G8-questionnaire and Timed Up and Go-test (TUG)) will be performed prior to start of treatment. Patients determined unfit are referred to a geriatrician for geriatric assessment and treatment advise. In care as usual, treatment decisions will be made on information from usual history taking and physical examination.
Main study parameters/endpoints: Primary endpoints include the percentage of started and completed (standard and adapted) therapy in patients with either geriatric screening care or care as usual. Secondary endpoints include health related quality of life; toxicity; progression free survival; overall survival and cost-effectiveness in terms of incremental costs per QALY from a societal perspective.
|- Main changes (audit trail)|
|- RECORD||8-jan-2018 - 11-jan-2018|