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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sykehuset Innlandet HF

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oslo University Hospital
Norwegian University of Science and Technology
St. Olavs Hospital
Oslo Metropolitan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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