Clinical trial NCT04644874: Geriatric Oncology Screening of Older Patients With Solid Cancers
Official title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Academy of Geriatric Cancer Research
name: Danish Cancer Society
name: University of Southern Denmark
First posted: 2020-11-25
Enrollment: 1401
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Global health status / Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Health-related Quality of Life (HRQoL)
timeFrame: 12 months
measure: Health-related Quality of Life (HRQoL)
timeFrame: 12 months
measure: Overall Survival
timeFrame: 12 months
measure: Cancer-specific Survival
timeFrame: 12 months
measure: Adherence to initial oncologic treatment plan
timeFrame: 12 months
measure: Adherence to initial oncologic treatment plan
timeFrame: 12 months
measure: Adherence to initial oncologic treatment plan
timeFrame: 12 months
measure: Performance analysis of the Geriatric 8
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
affiliation: University of Southern Denmark
name: Marianne Ewertz, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Department of Geriatric Medicin, Odense University Hospital
name: Jesper Ryg, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Medicin, Herlev and Gentofte Hospital
name: Cecilia M Lund, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Oncology, Odense University Hospital
name: Trine L Jørgensen, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Oncology, Odense University Hospital
name: Per Pfieffer, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Oncology, Odense University Hospital
name: Henrik J Ditzel, MD, DMSc
role: STUDY_CHAIR
References:
citation: 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.