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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071640
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Norwegian University of Science and Technology
St. Olavs Hospital
Oslo University Hospital
Oslo Metropolitan University
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Tracking Information
First Submitted Date February 16, 2017
First Posted Date March 7, 2017
Last Update Posted Date October 22, 2020
Actual Study Start Date February 22, 2017
Actual Primary Completion Date August 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2017)
  • physical function [ Time Frame: within 16 weeks after completion of EBRT ]
    as measured by the EORTC QLQ-C30
  • global quality of life [ Time Frame: within 16 weeks after completion of EBRT ]
    as measured by the EORTC QLQ-C30
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 1, 2017)
  • Dependency [ Time Frame: within 16 weeks after completion of EBRT ]
    As measured by the Nottingham Extended Activities of Daily Living
  • Use of inpatient services [ Time Frame: within 16 weeks after completion of EBRT ]
    inpatient days, hospital and nursing homes
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2017)
  • Feasibility of GA [ Time Frame: within 16 weeks after completion of EBRT ]
    Registered by questionnaires to participating cancer nurses
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: March 1, 2017)
  • Feasibility of GA [ Time Frame: within 16 weeks after completion of EBRT ]
    Registered by questionnaires to participating cancer nurses
  • Edmonton Frail Scale [ Time Frame: baseline and within 16 weeks after completion of EBRT ]
    we will test the precision of Edmonton Frail Scale in detecting frailty as compared to the more comprehensive GA
 
Descriptive Information
Brief Title Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy
Official Title Improving Quality of Life and Function for Older Cancer Patients Receiving Radiotherapy. Part IC: A Prospective Observational Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients >= 65 years of age referred for palliative or curative EBRT at the Radiotherapy Unit, Innlandet Hospital Trust
Condition
  • Elderly
  • Cancer
  • Radiotherapy Side Effect
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2018)
302
Original Estimated Enrollment
 (submitted: March 1, 2017)
325
Actual Study Completion Date July 19, 2020
Actual Primary Completion Date August 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03071640
Other Study ID Numbers 150356
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sykehuset Innlandet HF
Study Sponsor Sykehuset Innlandet HF
Collaborators
  • Norwegian University of Science and Technology
  • St. Olavs Hospital
  • Oslo University Hospital
  • Oslo Metropolitan University
Investigators
Principal Investigator: Marit Jordhøy Sykehuset Innlandet HF
PRS Account Sykehuset Innlandet HF
Verification Date October 2019