Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers

NCT04686851 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER
  • Danish Cancer Society

    collaborator OTHER
  • Academy of Geriatric Cancer

    collaborator UNKNOWN
  • Odense Patient Data Explorative Network

    collaborator OTHER
  • Region of Southern Denmark

    collaborator OTHER
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Ann-Kristine W Giger, MD · Department of Geriatric Medicine, Odense University Hospital, Odense

  • Cecilia M Lund, MD, PhD · Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen

  • Per Pfeiffer, MD, PhD · Department of Clinical Oncology, Odense University Hospital, Odense

  • Trine L Jørgensen, MD, PhD · Department of Clinical Oncology, Odense University Hospital, Odense

  • Marianne Ewertz, MD, DMSc · Institute of Clinical Research, University of Southern Denmark, Odense

  • Henrik Ditzel, MD, DMSc · Department og Geriatric Medicine, Odense University Hospital, Odense

  • Jesper Ryg, MD, PhD · Department of Geriatric Medicine, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-11-01
Completion
2024-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04686851 on ClinicalTrials.gov