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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071640
• Other study ID #: 150356
• Status: Completed
• 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
• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 19, 2020
• Est. primary completion date: August 13, 2018
• Gender: All
• Age group: 65 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Cancer
• Elderly
• Radiotherapy Side Effect

Locations

Country	Name	City	State
Norway	The Radiotherapy Unit, Innlandet Hospital Trust	Gjøvik

Sponsors (5)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Norwegian University of Science and Technology, Oslo Metropolitan University, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of GA	Registered by questionnaires to participating cancer nurses	within 16 weeks after completion of EBRT
Other	Edmonton Frail Scale	the precision of Edmonton Frail Scale in detecting frailty will be tested as compared to the more comprehensive GA	baseline and within 16 weeks after completion of EBRT
Primary	physical function	as measured by the EORTC QLQ-C30	within 16 weeks after completion of EBRT
Primary	global quality of life	as measured by the EORTC QLQ-C30	within 16 weeks after completion of EBRT
Secondary	Dependency	As measured by the Nottingham Extended Activities of Daily Living	within 16 weeks after completion of EBRT
Secondary	Use of inpatient services	inpatient days, hospital and nursing homes	within 16 weeks after completion of EBRT