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Oncogeriatric Intervention and Follow-up at Home

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: NCT02837679
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Marianne Ørum, Aarhus University Hospital

Brief Summary:

The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner.

The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,.

If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses.


Condition or disease Intervention/treatment Phase
Neoplasms Geriatric Assessment Lung Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Geriatrics Polypharmacy Quality of Life Other: Geriatric Follow up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 2019
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Intervention
Geriatric follow up
Other: Geriatric Follow up
No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Success rate of admittance to initial planned oncological treatment [ Time Frame: An average of 12 weeks ]
    Oncological specialist evaluates if treatment is completed as planned or if eventual deviations are of minor or major character

  2. Change in Quality of life (QoL) [ Time Frame: 90 days ]
    Participants with a Mini-Mental State Examination (MMSE)-score of 25 and above are tested using European Organisation of Research and Treatment of Cancer (EORTC) Core Questionnaire (C30) in combination with Elderly questionnaire (ELD14).

  3. Change in Quality of life [ Time Frame: 90 days ]
    Participants with a Mini-Mental State Examination (MMSE)-score below 25 are tested using "Depression List"


Secondary Outcome Measures :
  1. 90-day survival [ Time Frame: Within 90 days from first geriatric contact ]
    Are patients still alive 90 days after geriatric contact?

  2. Physical performance, chair-stand-test [ Time Frame: Changes in physical performance from first geriatric contact to 90 days after ]
    Physical performance is measured using chair-stand-test

  3. Physical performance, Barthel-100 [ Time Frame: Changes in physical performance from first geriatric contact to 90 days after ]
    Physical performance is measured using Barthel-100

  4. Physical performance, FAQ-IADL [ Time Frame: Changes in physical performance from first geriatric contact to 90 days after ]
    Physical performance is measured using Functional Activities Questionnaire (FAQ)-IADL

  5. Length of hospital stay [ Time Frame: Within 90 days from first geriatric contact ]
    Sum of hospital bed days in study period


Other Outcome Measures:
  1. 1-year mortality [ Time Frame: Within 1 year from first geriatric contact ]
    time to death within 1 year from geriatric contact

  2. 3-year mortality [ Time Frame: Within 3 year from first geriatric contact ]
    time to death within 3 years from geriatric contact

  3. 5-year mortality [ Time Frame: Within 5 year from first geriatric contact ]
    time to death within 5 years from geriatric contact

  4. Health costs per patient [ Time Frame: Outcome measure will be assessed from time of first geriatric contact and 90 days on (0-90 days) ]
    Costs used per patient at the hospital, in home care, by the GP and the pharmacy within 90 days after Comprehensive Geriatric Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

70 years or older with cancer of the head and neck, upper gastro intestinal cancer, colo-rectal cancer or Lung cancer, refered to Aarhus University Hospital for evaluation regarding oncological treatment on the Oncology Department at Aarhus University

  • Living in following municipalities: Odder (excl. of the island of Thunø), Faurskov, Skanderborg og Aarhus
  • frail or vulnerable by CGA
  • Signed informed consent. For incapacitated patients: informed consent by relatives

Exclusion Criteria:

  • evaluated 'fit´ by CGA
  • Referred to specialized palliative care at time of first visit at the Oncology department
  • Do not wish to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837679


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Danish Cancer Society
Investigators
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Principal Investigator: Marianne Ørum, MD Aarhus University Hospital
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Responsible Party: Marianne Ørum, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02837679    
Other Study ID Numbers: Onkogeriatri randomiseret
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases