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- Klinische proef NCT02072733
Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark
Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Aim:
The study aims 1)to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity and 4)to investigate the ability of CGA to predict complications to cancer treatment within a three months period.
Method:
All patients referred to the oncology Departement aged 70 years or more with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer, Living in the Central Denmark Region (Region Midt) are offered af Comprehensive Geriatric Assessment (CGA) on the day of the visit to the oncology outpatient Clinic. Prior to the first visit to the oncology department, the patients are informed that a CGA is planned..The CGA will take place at the outpatient clinic. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment.
Outcome:
- The possibility of offering CGA to elderly cancer patients in a larger area, the proportion of patients offered CGA by the oncogeriatric team compared to the actual number of elderly cancer patients assessed by oncologists during a three months period.
- The number of frail vs. vulnerable vs. fit persons is estimated from hospital records and the CGA observations. Their dependency in Activities of Daily Living (ADL) and Instrumental Activities og Daily Living (IADL), their cognitive, depressive and nutritional status and the medication problems are registered as well as the changes in patient´s medication.
- The impact of CGA on the oncologist´s treatment plan.
- The Complications, defined as discontinuation of treatment, hospitalization for other reasons than planned cancer treatment, or death, within the first three month following CGA.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Aarhus, Denemarken, 8000 C
- Geriatric Department Aarhus University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 70 years or older
- Patients from Central Denmark Region (Region Midtjylland)
- Lung cancer, Upper Gastrointestinal Cancer, cancer of head and neck and Colo-Rectal Cancer
- referred for assessment of treatment to the oncological department at Aarhus University Hospital.
Exclusion Criteria:
Patients referred to specialized palliative care at the first visit to the oncological outpatient clinic.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: geriatric assessment
The intervention is individual and based on the Comprehensive Geriatric assessment (CGA) : collection of information on comorbidity, polypharmacy, physical, psychological and cognitive functions, nutrition as well as social status and support. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment |
Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility
Tijdsspanne: 3 months
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Description of the proportion of patients who is available for CGA presented in percentage.
Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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frailty status
Tijdsspanne: 3 months
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Patient characteristics according to CGA status is presented in percentage
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3 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Impact of CGA on the oncologist´s treatment plan
Tijdsspanne: 3 months
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To analyse the association between the oncologist´s initial treatment plan (standard dose, reduced dose or supportive/palliative/no treatment) and the CGA conclusion (fit, vulnerable or frail) Pearson´s Chi-squared-test or Fisher´s Exact test is used. In a subgroup analysis on the non-agreed category data on the CGA conclusion and the oncologist´s initial treatment plan. And furthermore to compare the oncologist´s final treatment intensity to the CGA recommendations Pearson´s Chi-squared-test or Fisher´s Exact test are used |
3 months
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Complications
Tijdsspanne: 3 months
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Description of the proportion of patients who is available for CGA presented in percentage.
Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.
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3 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Else Marie Damsgaard, Professor, Geriatric Department Aarhus University Hospital Denmark
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Oncogeriatric feasibility
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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