Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
NCT ID: NCT04686851
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
322 participants
INTERVENTIONAL
2020-11-01
2024-06-01
Brief Summary
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Detailed Description
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Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.
The randomized groups will be compared with respect to primary and secondary endpoints.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care
Comprehensive Geriatric Assessment and follow-up
All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.
Follow-up on initial treatment plan is scheduled to one month after baseline CGA.
Control
standard oncologic care according to national guidelines
No interventions assigned to this group
Interventions
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Comprehensive Geriatric Assessment and follow-up
All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.
Follow-up on initial treatment plan is scheduled to one month after baseline CGA.
Eligibility Criteria
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Inclusion Criteria
* Living in the region of Southern Denmark
* Newly diagnosed solid tumours assessed eligible for antineoplastic treatment
* Vulnerable or frail (G8 ≤ 14)
Exclusion Criteria
* Inability to give informed consent
* Already consulting geriatric outpatient clinic
* Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year
70 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Danish Cancer Society
OTHER
Academy of Geriatric Cancer
UNKNOWN
Odense Patient Data Explorative Network
OTHER
Region of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Ann-Kristine Weber Giger
Principal Investigator
Principal Investigators
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Ann-Kristine W Giger, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Geriatric Medicine, Odense University Hospital, Odense
Cecilia M Lund, MD, PhD
Role: STUDY_CHAIR
Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen
Per Pfeiffer, MD, PhD
Role: STUDY_CHAIR
Department of Clinical Oncology, Odense University Hospital, Odense
Trine L Jørgensen, MD, PhD
Role: STUDY_CHAIR
Department of Clinical Oncology, Odense University Hospital, Odense
Marianne Ewertz, MD, DMSc
Role: STUDY_CHAIR
Institute of Clinical Research, University of Southern Denmark, Odense
Henrik Ditzel, MD, DMSc
Role: STUDY_CHAIR
Department og Geriatric Medicine, Odense University Hospital, Odense
Jesper Ryg, MD, PhD
Role: STUDY_DIRECTOR
Department of Geriatric Medicine, Odense University Hospital
Locations
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Odense University Hospital
Odense, Southern Denmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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Jesper Ryg, MD, Prof.
Role: primary
References
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Giger AW, Ditzel HM, Ditzel HJ, Ewertz M, Jorgensen TL, Pfeiffer P, Lund CM, Ryg J. Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer: A randomized controlled trial (PROGNOSIS-RCT). J Geriatr Oncol. 2024 Jan;15(1):101658. doi: 10.1016/j.jgo.2023.101658. Epub 2023 Nov 6.
Giger AW, Ditzel HM, Jorgensen TL, Ditzel HJ, Mohammadnejad A, Ewertz M, Pfeiffer P, Lund CM, Ryg J. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT). J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.
Other Identifiers
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R247-A14382
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20/ 17768
Identifier Type: OTHER
Identifier Source: secondary_id
PROGNOSIS-RCT
Identifier Type: -
Identifier Source: org_study_id