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

NCT ID: NCT03071640

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-22

Study Completion Date

2020-07-19

Brief Summary

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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.

Detailed Description

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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

Conditions

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Elderly Cancer Radiotherapy Side Effect

Keywords

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old elderly radiotherapy geriatric assessment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marit Jordhøy

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet HF

Locations

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The Radiotherapy Unit, Innlandet Hospital Trust

Gjøvik, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 36180379 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35877269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34874228 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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150356

Identifier Type: -

Identifier Source: org_study_id