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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Elderly; Radiotherapy Side Effect

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

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• Norway
  • Gjøvik, Norway
    • The Radiotherapy Unit, Innlandet Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients >= 65 years of age referred for palliative or curative EBRT at the Radiotherapy Unit, Innlandet Hospital Trust

Description

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:

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical function	as measured by the EORTC QLQ-C30	within 16 weeks after completion of EBRT
global quality of life	as measured by the EORTC QLQ-C30	within 16 weeks after completion of EBRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dependency	As measured by the Nottingham Extended Activities of Daily Living	within 16 weeks after completion of EBRT
Use of inpatient services	inpatient days, hospital and nursing homes	within 16 weeks after completion of EBRT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of GA	Registered by questionnaires to participating cancer nurses	within 16 weeks after completion of EBRT
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

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: Oslo University Hospital; Norwegian University of Science and Technology; St. Olavs Hospital; Oslo Metropolitan University
• Investigators: Principal Investigator: Marit Jordhøy, Sykehuset Innlandet HF

Publications and helpful links

General Publications

• 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. 2022 Sep 27:S1879-4068(22)00227-2. doi: 10.1016/j.jgo.2022.09.008. Online ahead of print.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): July 19, 2020

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: radiotherapy; elderly; geriatric assessment; old
• Other Study ID Numbers: 150356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No