NCT03071640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2020

Completed
Last Updated

December 10, 2021

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

February 16, 2017

Last Update Submit

December 9, 2021

Conditions

ElderlyCancerRadiotherapy Side Effect

Keywords

oldelderlyradiotherapygeriatric assessment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Dependency

    within 16 weeks after completion of EBRT

  • Use of inpatient services

    within 16 weeks after completion of EBRT

Other Outcomes (2)

  • Feasibility of GA

    within 16 weeks after completion of EBRT

  • Edmonton Frail Scale

    baseline and within 16 weeks after completion of EBRT

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Radiotherapy Unit, Innlandet Hospital Trust

Gjøvik, Norway

Location

Related Publications (3)

  • 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.

    PMID: 36180379DERIVED

  • 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.

    PMID: 35877269DERIVED

  • 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.

    PMID: 34874228DERIVED

MeSH Terms

Conditions

NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Marit Jordhøy

    Sykehuset Innlandet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 7, 2017

Study Start

February 22, 2017

Primary Completion

August 13, 2018

Study Completion

July 19, 2020

Last Updated

December 10, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)