Geriatric Oncology Screening of Older Patients With Solid Cancers

NCT ID: NCT04644874

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1401 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2022-11-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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,

Geriatric 8

Intervention Type: 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.

modified Geriatric 8

Intervention Type: 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.

30 second chair stand test

Intervention Type: DIAGNOSTIC_TEST

Repetitions within 30 seconds

Handgrip Strength Test

Intervention Type: DIAGNOSTIC_TEST

Measured in kilograms

Interventions

Geriatric 8

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.

Intervention Type: DIAGNOSTIC_TEST

modified Geriatric 8

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.

Intervention Type: DIAGNOSTIC_TEST

30 second chair stand test

Repetitions within 30 seconds

Intervention Type: DIAGNOSTIC_TEST

Handgrip Strength Test

Measured in kilograms

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

G8; mG8; 30s-CST; chair stand test; 30 CST; CST; sit-to-stand test; 30 s chair stand test; HGST; HST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Geriatric Cancer Research

UNKNOWN

Sponsor Role: collaborator

Danish Cancer Society

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helena Ditzel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne Ewertz, MD, DMSc

Role: STUDY_DIRECTOR

University of Southern Denmark

Jesper Ryg, MD, PhD

Role: STUDY_CHAIR

Department of Geriatric Medicin, Odense University Hospital

Cecilia M Lund, MD, PhD

Role: STUDY_CHAIR

Department of Clinical Medicin, Herlev and Gentofte Hospital

Trine L Jørgensen, MD, PhD

Role: STUDY_CHAIR

Department of Oncology, Odense University Hospital

Per Pfieffer, MD, PhD

Role: STUDY_CHAIR

Department of Oncology, Odense University Hospital

Henrik J Ditzel, MD, DMSc

Role: STUDY_CHAIR

Department of Oncology, Odense University Hospital

Locations

Odense University Hospital

Odense, Fyn, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34176752 (View on PubMed)

Other Identifiers

R247-A14382

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20/ 17768

Identifier Type: OTHER

Identifier Source: secondary_id

PROGNOSIS-G8

Identifier Type: -

Identifier Source: org_study_id