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Completed

NCT Number: NCT03071640

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

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.

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Key information

Conditions

Elderly Cancer Neoplasms Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Radiotherapy Unit, Innlandet Hospital Trust

Gjøvik, Norway

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. physical function

    Time frame: within 16 weeks after completion of EBRT

    as measured by the EORTC QLQ-C30

  2. global quality of life

    Time frame: within 16 weeks after completion of EBRT

    as measured by the EORTC QLQ-C30

Secondary outcomes

  1. Dependency

    Time frame: within 16 weeks after completion of EBRT

    As measured by the Nottingham Extended Activities of Daily Living

  2. Use of inpatient services

    Time frame: within 16 weeks after completion of EBRT

    inpatient days, hospital and nursing homes

Other outcomes

  1. Feasibility of GA

    Time frame: within 16 weeks after completion of EBRT

    Registered by questionnaires to participating cancer nurses

  2. 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

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Norwegian University of Science and Technology
  • Oslo Metropolitan University
  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy. Part IC: A Prospective Observational Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Mar 7, 2017
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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