Oncogeriatric Intervention and Follow-up at Home
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|ClinicalTrials.gov Identifier: NCT02837679|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : April 29, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Geriatric follow up
Other: Geriatric Follow up
No Intervention: Control
- 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
- 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).
- 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"
- 90-day survival [ Time Frame: Within 90 days from first geriatric contact ]Are patients still alive 90 days after geriatric contact?
- 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
- 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
- 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
- Length of hospital stay [ Time Frame: Within 90 days from first geriatric contact ]Sum of hospital bed days in study period
- 1-year mortality [ Time Frame: Within 1 year from first geriatric contact ]time to death within 1 year from geriatric contact
- 3-year mortality [ Time Frame: Within 3 year from first geriatric contact ]time to death within 3 years from geriatric contact
- 5-year mortality [ Time Frame: Within 5 year from first geriatric contact ]time to death within 5 years from geriatric contact
- 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
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
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Marianne Ørum, MD||Aarhus University Hospital|