Spots Global Cancer Trial Database for Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
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Trial Identification
Brief Title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
Official Title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)
Study ID: NCT04686851
Interventions
Study Description
Brief Summary: A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.
Detailed Description: This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design. 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.
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Odense University Hospital, Odense, Southern Denmark, Denmark
Contact Details
Name: Ann-Kristine W Giger, MD
Affiliation: Department of Geriatric Medicine, Odense University Hospital, Odense
Role: PRINCIPAL_INVESTIGATOR
Name: Cecilia M Lund, MD, PhD
Affiliation: Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen
Role: STUDY_CHAIR
Name: Per Pfeiffer, MD, PhD
Affiliation: Department of Clinical Oncology, Odense University Hospital, Odense
Role: STUDY_CHAIR
Name: Trine L Jørgensen, MD, PhD
Affiliation: Department of Clinical Oncology, Odense University Hospital, Odense
Role: STUDY_CHAIR
Name: Marianne Ewertz, MD, DMSc
Affiliation: Institute of Clinical Research, University of Southern Denmark, Odense
Role: STUDY_CHAIR
Name: Henrik Ditzel, MD, DMSc
Affiliation: Department og Geriatric Medicine, Odense University Hospital, Odense
Role: STUDY_CHAIR
Name: Jesper Ryg, MD, PhD
Affiliation: Department of Geriatric Medicine, Odense University Hospital
Role: STUDY_DIRECTOR
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