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

NCT04686851 | Unknown DMC

• 3 other identifiers: PROGNOSIS-RCTR247-A1438220/ 17768
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Cancer; Age

Keywords

Frailty; Aged; Neoplasms; Cancer Patients; Geriatric Screening; Geriatric 8; Geriatric Assessment; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• physical function for patients receiving palliative oncologic treatment

  measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.

  3 months

• unplanned hospital admissions for patients receiving adjuvant oncologic treatment

  number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.

  6 months

Secondary Outcomes (14)

• Physical functional for patients receiving curative oncologic treatment

  3 months

• Physical functional for patients receiving curative oncologic treatment

  6 months

• Physical functional for patients receiving palliative oncologic treatment

  6 months

• number of unplanned hospital admissions for patients receiving palliative oncologic treatment

  6 months

• Health-related Quality of life

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care

Other: Comprehensive Geriatric Assessment and follow-up

Control

NO INTERVENTION

standard oncologic care according to national guidelines

Interventions

Comprehensive Geriatric Assessment and follow-up OTHER

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.

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• Living in the region of Southern Denmark
• Newly diagnosed solid tumours assessed eligible for antineoplastic treatment
• Vulnerable or frail (G8 ≤ 14)

You may not qualify if:

• Inability to speak or understand Danish
• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Danish Cancer Society: collaborator
• Academy of Geriatric Cancer: collaborator
• Odense Patient Data Explorative Network: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, Southern Denmark, 5000, Denmark

RECRUITING

Related Publications (2)

• 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.

  PMID: 37939628 DERIVED

• 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.

  PMID: 34362713 DERIVED

MeSH Terms

Conditions

Frailty; Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ann-Kristine W Giger, MD

  Department of Geriatric Medicine, Odense University Hospital, Odense

  PRINCIPAL INVESTIGATOR

• Cecilia M Lund, MD, PhD

  Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen

  STUDY CHAIR

• Per Pfeiffer, MD, PhD

  Department of Clinical Oncology, Odense University Hospital, Odense

  STUDY CHAIR

• Trine L Jørgensen, MD, PhD

  Department of Clinical Oncology, Odense University Hospital, Odense

  STUDY CHAIR

• Marianne Ewertz, MD, DMSc

  Institute of Clinical Research, University of Southern Denmark, Odense

  STUDY CHAIR

• Henrik Ditzel, MD, DMSc

  Department og Geriatric Medicine, Odense University Hospital, Odense

  STUDY CHAIR

• Jesper Ryg, MD, PhD

  Department of Geriatric Medicine, Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jesper Ryg, MD

CONTACT

60152610; Jesper.Ryg@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial with 2 randomized 1:1 parallel study groups

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: December 29, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: June 1, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

DK (1)