Geriatric Oncology Screening of Older Patients With Solid Cancers

NCT04644874 | Completed DMC

• 3 other identifiers: PROGNOSIS-G8R247-A1438220/ 17768
• Study Type: observational
• Target: 1,401
• Locations: 1 country
• Sites: 1

Brief Summary

Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Currently, there are no guidelines for oncogeriatric screening in older cancer patients in Denmark. We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA. Aims:

• Determine whether Danish cancer patients, with a G8 score of ≤14, experience poorer quality of life (QoL), receive less recommended standard cancer treatment, experience more treatment-related toxicity, stop treatment earlier, and experience shorter survival than patients with a G8 score \>14.
• Ascertain whether the standard G8 cut-off score of ≤14 is the most relevant cut-off score, with respect to treatment adherence, treatment-related toxicity, QoL, and survival, when focusing on the older Danish cancer patient population.
• Establish whether the performance and prognostic value of the G8 can be strengthened through the addition of a functional measure, the 30-second chair stand test (30-CST), and/ or the handgrip strength test (HGST).
• Evaluate the prognostic value of the modified Geriatric 8 (mG8) Methods: A prospective, descriptive study of all outpatients with newly diagnosed solid tumors at the Department of Oncology, Odense University Hospital, age 70 years or more. Patients will be screened with the G8, mG8, 30-CST, HGST, and QoL questionnaires at baseline with subsequent one-year follow-up, to determine the prognostic value of the G8 and the mG8. An initial two-month pilot study will help determine inclusion rates and highlight necessary practical adjustments to ensure optimal study participation. Baseline characteristics will be compared with descriptive statistics. Our primary endpoint; Global Health status/ QoL (EORTC QLQ-C30 \& QLQ-ELD14), and secondary endpoints; treatment adherence, and treatment-related toxicity, will be assessed using logistical regression; while secondary endpoints; overall survival, cancer-specific survival, will be assessed using the Kaplan Meier analysis and Cox proportional hazard models. Post hoc diagnostic performance analysis will be conducted to determine the optimal G8 cut-off and whether functional measures (30-CST and HGST) can enhance screening accuracy.

Conditions

Solid Carcinoma; Frailty; Age; Geriatrics; Screening; Cancer

Keywords

Older adults; Cancer patients; Neoplasms; Frailty; Comprehensive geriatric assessment; Geriatric screening; Geriatric 8; modified Geriatric 8; G8; mG8; elderly; screening

Outcome Measures

Primary Outcomes (1)

• Global health status / Quality of Life

  Global health status will be described using EORTC QLQ-C30

  12 months

Secondary Outcomes (8)

• Health-related Quality of Life (HRQoL)

  12 months

• Health-related Quality of Life (HRQoL)

  12 months

• Overall Survival

  12 months

• Cancer-specific Survival

  12 months

• Adherence to initial oncologic treatment plan

  12 months

Study Arms (1)

Older cancer patients

All outpatients, age 70 years or more, with solid malignancies, referred to the Department of Oncology at Odense University Hospital for 1st line antineoplastic treatment or information,

Diagnostic Test: Geriatric 8; Diagnostic Test: modified Geriatric 8; Diagnostic Test: 30 second chair stand test; Diagnostic Test: Handgrip Strength Test

Interventions

Geriatric 8 DIAGNOSTIC_TEST

The G8 is an eight-item screening tool, developed for older cancer patients. The G8 score ranges from 0 (heavily impaired) to 17 (not at all impaired), with a cut-off for potential frailty of ≤14.

Also known as: G8

Older cancer patients

modified Geriatric 8 DIAGNOSTIC_TEST

The mG8 is a modified version of the Geriatric 8 screening tool, consisting of 6-items. The mG8 score ranges from 0 (not at all impaired) to 35 (heavily impaired), with a cut-off for potential frailty at ≥6.

Also known as: mG8

Older cancer patients

30 second chair stand test DIAGNOSTIC_TEST

Repetitions within 30 seconds

Also known as: 30s-CST, chair stand test, 30 CST, CST, sit-to-stand test, 30 s chair stand test

Older cancer patients

Handgrip Strength Test DIAGNOSTIC_TEST

Measured in kilograms

Also known as: HGST, HST

Older cancer patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All outpatients, age 70 years or more with solid malignancies, referred to the Department of Oncology at Odense University Hospital for antineoplastic treatment or information

You may qualify if:

• Patients age ≥70 with solid tumors (not hematological malignancies nor non-melanoma skin cancer) referred to the outpatient clinic at Odense University Hospital for information and/or antineoplastic treatment
• Patients must be able to give informed consent
• Patients must be able to speak English or Danish

You may not qualify if:

• Patients who have received antineoplastic treatment for another cancer diagnosis within the past year
• Patients who have begun chemotherapy or immunotherapy for the referred cancer diagnosis, more than 48 hours prior to the time of consent
• Patients who have begun other antineoplastic treatment (not endocrine) for the referred cancer diagnosis, more than 7 days prior to the time of consent

Sponsors & Collaborators

• Odense University Hospital: lead
• Academy of Geriatric Cancer Research: collaborator
• Danish Cancer Society: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (1)

• Ditzel HM, Giger AW, Lund CM, Ditzel HJ, Mohammadnejad A, Pfeiffer P, Ryg J, Jorgensen TL, Ewertz M. Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients with Solid Cancers: Protocol for a Danish prospective cohort study (PROGNOSIS-G8). J Geriatr Oncol. 2021 Nov;12(8):1270-1276. doi: 10.1016/j.jgo.2021.06.004. Epub 2021 Jun 25.

  PMID: 34176752 DERIVED

MeSH Terms

Conditions

Frailty; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Ewertz, MD, DMSc

  University of Southern Denmark

  STUDY DIRECTOR

• Jesper Ryg, MD, PhD

  Department of Geriatric Medicin, Odense University Hospital

  STUDY CHAIR

• Cecilia M Lund, MD, PhD

  Department of Clinical Medicin, Herlev and Gentofte Hospital

  STUDY CHAIR

• Trine L Jørgensen, MD, PhD

  Department of Oncology, Odense University Hospital

  STUDY CHAIR

• Per Pfieffer, MD, PhD

  Department of Oncology, Odense University Hospital

  STUDY CHAIR

• Henrik J Ditzel, MD, DMSc

  Department of Oncology, Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 25, 2020
• Study Start: June 3, 2020
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)