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Brief Title: 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 ID: NCT04644874
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.
Detailed Description:
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Odense University Hospital, Odense, Fyn, Denmark
Name: Marianne Ewertz, MD, DMSc
Affiliation: University of Southern Denmark
Role: STUDY_DIRECTOR
Name: Jesper Ryg, MD, PhD
Affiliation: Department of Geriatric Medicin, Odense University Hospital
Role: STUDY_CHAIR
Name: Cecilia M Lund, MD, PhD
Affiliation: Department of Clinical Medicin, Herlev and Gentofte Hospital
Role: STUDY_CHAIR
Name: Trine L Jørgensen, MD, PhD
Affiliation: Department of Oncology, Odense University Hospital
Role: STUDY_CHAIR
Name: Per Pfieffer, MD, PhD
Affiliation: Department of Oncology, Odense University Hospital
Role: STUDY_CHAIR
Name: Henrik J Ditzel, MD, DMSc
Affiliation: Department of Oncology, Odense University Hospital
Role: STUDY_CHAIR