Clinical trial NCT04686851: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Cancer
Age
Keywords: Frailty
Aged
Neoplasms
Cancer Patients
Geriatric Screening
Geriatric 8
Geriatric Assessment
Randomized Clinical Trial
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Danish Cancer Society
name: Academy of Geriatric Cancer
name: Odense Patient Data Explorative Network
name: Region of Southern Denmark
First posted: 2020-12-29
Enrollment: 322
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with 2 randomized 1:1 parallel study groups
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Age ≥ 70 years
* 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 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

Primary outcomes:
measure: physical function for patients receiving palliative oncologic treatment
timeFrame: 3 months
measure: unplanned hospital admissions for patients receiving adjuvant oncologic treatment
timeFrame: 6 months
Secondary outcomes:
measure: Physical functional for patients receiving curative oncologic treatment
timeFrame: 3 months
measure: Physical functional for patients receiving curative oncologic treatment
timeFrame: 6 months
measure: Physical functional for patients receiving palliative oncologic treatment
timeFrame: 6 months
measure: number of unplanned hospital admissions for patients receiving palliative oncologic treatment
timeFrame: 6 months
measure: Health-related Quality of life
timeFrame: 12 months
measure: Health-related Quality of life
timeFrame: 12 months follow-up
measure: Elderly Functional Index Score (ELFI-score)
timeFrame: 6 months
measure: Number of patients who experience oncologic treatment toxicity
timeFrame: 6 months
measure: Number of patients with adherence to initial oncologic treatment plan
timeFrame: 6 months
measure: Degree of Polypharmacy (PP)
timeFrame: 3 months
measure: Number of potential Inappropriate Medications (PIM)
timeFrame: 3 months
measure: Number of Potential Drug Interactions (PDI)
timeFrame: 3 months
measure: Overall survival
timeFrame: 12 months
measure: Cancer specific survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Southern Denmark
Study officials:
affiliation: Department of Geriatric Medicine, Odense University Hospital, Odense
name: Ann-Kristine W Giger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen
name: Cecilia M Lund, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Oncology, Odense University Hospital, Odense
name: Per Pfeiffer, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Oncology, Odense University Hospital, Odense
name: Trine L Jørgensen, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Clinical Research, University of Southern Denmark, Odense
name: Marianne Ewertz, MD, DMSc
role: STUDY_CHAIR
affiliation: Department og Geriatric Medicine, Odense University Hospital, Odense
name: Henrik Ditzel, MD, DMSc
role: STUDY_CHAIR
affiliation: Department of Geriatric Medicine, Odense University Hospital
name: Jesper Ryg, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.