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Spots Global Cancer Trial Database for Geriatric Oncology Screening of Older Patients With Solid Cancers

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Odense University Hospital, Odense, Fyn, Denmark

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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