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

December 9, 2021 updated by: Sykehuset Innlandet HF

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dependency
Time Frame: within 16 weeks after completion of EBRT
As measured by the Nottingham Extended Activities of Daily Living
within 16 weeks after completion of EBRT
Use of inpatient services
Time Frame: within 16 weeks after completion of EBRT
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
Time Frame: within 16 weeks after completion of EBRT
Registered by questionnaires to participating cancer nurses
within 16 weeks after completion of EBRT
Edmonton Frail Scale
Time Frame: baseline and within 16 weeks after completion of EBRT
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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