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Completed

NCT Number: NCT04644874

Geriatric Oncology Screening of Older Patients With Solid Cancers

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.

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Key information

Conditions

Solid Carcinoma Age Cancer Frailty Geriatrics Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Screening

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, Fyn, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: G8

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.

Other names: mG8

30 second chair stand test

Diagnostic Test

Repetitions within 30 seconds

Other names: 30s-CST, chair stand test, 30 CST, CST, sit-to-stand test, 30 s chair stand test

Handgrip strength test

Diagnostic Test

Measured in kilograms

Other names: HGST, HST

Primary outcomes

  1. Global health status / Quality of Life

    Time frame: 12 months

    Global health status will be described using EORTC QLQ-C30

Secondary outcomes

  1. Health-related Quality of Life (HRQoL)

    Time frame: 12 months

    HRQoL is measured by EORTC QLQ-C30

  2. Health-related Quality of Life (HRQoL)

    Time frame: 12 months

    HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)

  3. Overall Survival

    Time frame: 12 months

    Overall Survival is measured from Geriatric 8 screening to time of death

  4. Cancer-specific Survival

    Time frame: 12 months

    Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer

  5. Adherence to initial oncologic treatment plan

    Time frame: 12 months

    Deviation from initial oncologic treatment plan with the registration of dose reductions, with the given dose measured as a percentage of the planned dose.

  6. Adherence to initial oncologic treatment plan

    Time frame: 12 months

    Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.

  7. Adherence to initial oncologic treatment plan

    Time frame: 12 months

    Deviation from initial oncologic treatment plan with the registration of discontinuation of treatment, measured as the number of given cycles divided by the number of planned cycles.

  8. Performance analysis of the Geriatric 8

    Time frame: 12 months

    Performance analysis will be conducted using patients allocated to Comprehensive Geriatric Assessment (CGA), where an abnormal CGA will be defined as >1 abnormal domain, in accordance with the Danish version of the Geriatric Core Dataset (G-Code).

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Academy of Geriatric Cancer Research
  • Danish Cancer Society
  • University of Southern Denmark

Registry information

Official study title

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study

Acronym: PROGNOSIS-G8

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2020
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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