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Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy

Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy. Part IC: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03071640
Enrollment
302
Registered
2017-03-07
Start date
2017-02-22
Completion date
2020-07-19
Last updated
2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Elderly, Radiotherapy Side Effect

Keywords

old, elderly, radiotherapy, geriatric assessment

Brief 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.

Detailed 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

Interventions

None listed

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Oslo Metropolitan University
CollaboratorOTHER
Sykehuset Innlandet HF
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

Inclusion criteria

* Patients \>= 65 years of age * histologically confirmed cancer diagnoses * referred for palliative or curative EBRT * living in the hospital catchment area, able to understand and fill in self-report questionnaires * fluent in Norwegian (orally and in writing), provide written, informed consent

Design outcomes

Primary

MeasureTime frameDescription
physical functionwithin 16 weeks after completion of EBRTas measured by the EORTC QLQ-C30
global quality of lifewithin 16 weeks after completion of EBRTas measured by the EORTC QLQ-C30

Secondary

MeasureTime frameDescription
Dependencywithin 16 weeks after completion of EBRTAs measured by the Nottingham Extended Activities of Daily Living
Use of inpatient serviceswithin 16 weeks after completion of EBRTinpatient days, hospital and nursing homes

Other

MeasureTime frameDescription
Feasibility of GAwithin 16 weeks after completion of EBRTRegistered by questionnaires to participating cancer nurses
Edmonton Frail Scalebaseline and within 16 weeks after completion of EBRTthe precision of Edmonton Frail Scale in detecting frailty will be tested as compared to the more comprehensive GA

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026