Geriatric and Oncologic Assessment Before Treatment

Not Applicable

• Conditions: Cancer
• Interventions: Other: G8 screening; Other: Geriatric assessment

• Registration Number: NCT02671994
• Lead Sponsor: Odense University Hospital

Brief Summary

In a randomized controlled trial, the investigators wish to investigate, if oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to standard assessment (PS and clinical assessment) in oncologic treatment decision.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Histologically verified gynaecologic cancer (ovarian, uterine, or cervical cancer) or urologic cancer (prostate, bladder, or kidney cancer).
• Suited for first line medical oncologic treatment with chemotherapy and/or targeted therapy.
• Age ≥ 70 years.
• Understands, speaks, and writes Danish.
• Signed informed consent.

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Exclusion Criteria

• Previous cancer diagnosis except for carcinoma in situ of the cervix or skin cancer other than malignant melanoma.
• Previous chemotherapy and/or targeted therapy for current cancer diagnosis.
• Previous radiation therapy or concomitant radiotherapy for current cancer diagnosis.
• Surgery within the last 4 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (experimental group)	G8 screening	Oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in addition to standard assessment (ECOG Performance Status + clinical assessment).
A (experimental group)	Geriatric assessment	Oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in addition to standard assessment (ECOG Performance Status + clinical assessment).

Primary Outcome Measures

Name	Time	Method
Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)	2 years

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark