Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03071640 |
Other study ID # |
150356 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 22, 2017 |
Est. completion date |
July 19, 2020 |
Study information
Verified date |
October 2019 |
Source |
Sykehuset Innlandet HF |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study is a first part of a larger project aiming at improving the following outcomes in
older cancer patients receiving external beam radiation therapy (EBRT): quality of life,
functioning and need for professional help (dependency). To achieve this, the investigators
will develop and test a geriatric assessment (GA) with management (GAM) intervention
targeting patients at risk of negative outcomes as defined. The problems and needs that older
patients experience before, during and after EBRT are poorly described. Furthermore, although
GA is the recommended approach to assess older cancer patients' vulnerability, very few
studies have investigated its benefit and feasibility in a radiotherapy setting and there is
no universal recipe for how an efficient GAM intervention should be applied in this setting.
Before defining and testing an intervention, the investigators will therefore conduct an
observational study addressing older patients >= 65 years referred for either palliative or
curative EBRT. The main objectives are to identify patients at risk for negative outcomes,
and to test the feasibility of GA in the community service and at a radiotherapy department.
Description:
GA includes a systematic assessment of area where older people often have problems, i.e.
assessment of comorbidity, medication, functional status and physical functioning, cognitive
function, nutritional status, and depression. In this observational study, the assessment
will be performed using well-established instruments and tests before start and after
completion of radiotherapy. The patient will be followed-up by repeated assessments at week
2, 8 and 16 post treatment. Quality of life (QoL) questionnaires will be filled in by
self-report at the same points in time. Follow-up data will also include information on the
patients' use of health services (home-, nursing home and hospital care). Additionally
available diagnostic CT scans will also be used for analyses of nutritional status and body
composition. Eligible patients will be included at the Radiotherapy Unit, Innlandet Hospital
Trust after having given written informed consent. A project nurse (cancer nurse) will
perform the assessments at the Radiotherapy Unit, whereas follow-up assessments will be
performed by community cancer nurses. All municipalities in the hospital catchment area are
invited to participate in the study. The study will be conducted in co-operation with several
national and international partners, including partners from the local municipalities