Clinical trial NCT03071640: Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy
Official title: Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy. Part IC: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Cancer
Radiotherapy Side Effect
Keywords: old
elderly
radiotherapy
geriatric assessment
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: St. Olavs Hospital
name: Oslo University Hospital
name: Oslo Metropolitan University
First posted: 2017-03-07
Enrollment: 302
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \>= 65 years of age referred for palliative or curative EBRT at the Radiotherapy Unit, Innlandet Hospital Trust

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

Eligibility criteria: 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

Exclusion Criteria:

Primary outcomes:
measure: physical function
timeFrame: within 16 weeks after completion of EBRT
measure: global quality of life
timeFrame: within 16 weeks after completion of EBRT
Secondary outcomes:
measure: Dependency
timeFrame: within 16 weeks after completion of EBRT
measure: Use of inpatient services
timeFrame: within 16 weeks after completion of EBRT
Other outcomes:
measure: Feasibility of GA
timeFrame: within 16 weeks after completion of EBRT
measure: Edmonton Frail Scale
timeFrame: baseline and within 16 weeks after completion of EBRT
Locations:
city: Gjøvik
country: Norway
facility: The Radiotherapy Unit, Innlandet Hospital Trust
Study officials:
affiliation: Sykehuset Innlandet HF
name: Marit Jordhøy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksen GF, Benth JS, Gronberg BH, Rostoft S, Kirkhus L, Kirkevold O, Oldervoll LM, Bye A, Hjelstuen A, Slaaen M. Geriatric impairments are associated with reduced quality of life and physical function in older patients with cancer receiving radiotherapy - A prospective observational study. J Geriatr Oncol. 2023 Jan;14(1):101379. doi: 10.1016/j.jgo.2022.09.008. Epub 2022 Sep 27.
citation: Eriksen GF, Saltyte Benth J, Gronberg BH, Rostoft S, Kirkevold O, Bergh S, Hjelstuen A, Rolfson D, Slaaen M. Cognitive Trajectories in Older Patients with Cancer Undergoing Radiotherapy-A Prospective Observational Study. Curr Oncol. 2022 Jul 21;29(7):5164-5178. doi: 10.3390/curroncol29070409.
citation: Eriksen GF, Saltyte Benth J, Gronberg BH, Rostoft S, Kirkhus L, Kirkevold O, Hjelstuen A, Slaaen M. Geriatric impairments are prevalent and predictive of survival in older patients with cancer receiving radiotherapy: a prospective observational study. Acta Oncol. 2022 Apr;61(4):393-402. doi: 10.1080/0284186X.2021.2009561. Epub 2021 Dec 7.