The primary objective is 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 and to assess whether geriatric screening tests provide a…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters are the percentage started and completed treatment
in *geriatric screening care* and *care as usual* and the difference in
percentage in completed treatment (either standard or adapted) between 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.
Background summary
Treatment of advanced stage ovarian cancer consists of cytoreductive surgery in
combination with chemotherapy. Forty percent of patients diagnosed with ovarian
cancer is >= 70 years of age. Data shows treatment is started less frequently
with increasing age. Also, 1:4 older patients who has started treatment was
unable to finish this intensive therapy, resulting in loss of quality of life
without survival benefit. It remains difficult to differentiate patients who
are fit for standard treatment from those who may benefit from adjusted
treatment. Geriatric assessment is thought to improve tailored therapy for
vulnerable patients. Incorporation of geriatric screening tests into work-up
for ovarian cancer therapy might improve completion of treatment in this
population.
Study objective
The primary objective is 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 and to assess whether geriatric screening
tests provide a better identification of patients who are fit for standard
treatment or who need an adapted treatment.
Secondary objectives include identifying toxicity, quality of life, survival
and cost-effectiveness of the addition of geriatric screening to ovarian cancer
therapy.
Study design
This study is a pragmatic, cluster randomized controlled trial. Twenty
hospitals will be randomized to either usual care or geriatric screening care.
In this longitudinal study, patients are included immediately after initial
diagnosis of ovarian cancer with a follow-up of 24 months. A total of 320
patients will be included in the study.
Geriatric screening care: two geriatric screening tests (TUG and
G8-questionnaire) are performed before a treatment strategy is defined.
Patients scoring unfit will be referred to a geriatrician, resulting in a
adapted treatment strategy. When scored fit, patients will receive standard
treatment.
Care as usual: care is provided in agreement with the Dutch guidelines.
Data on health related quality of life and resource use will be obtained by
means of questionnaires at four points in time: before, during and after
treatment. Clinical, socioeconomic and resource use data will be collected from
patient files.
Study burden and risks
Patients are asked to complete four sets of four questionnaires concerning
quality of life on T=0, T=6, T=12 and T=24 months after initial diagnosis.
Patients in *geriatric screening care* receive two short geriatric screening
tests (+/- 10 minutes) and are referred to a geriatrician when considered
necessary. The questionnaires and the geriatric screening tests are considered
safe and not very burdensome. No major risk are expected. Elderly patients with
ovarian cancer as a group are considered to benefit from the study in the
future.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- A woman with high suspicion of OR 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62356.031.17 |
| Other | NTR-nummer: NL6745 |