NCT04300699: FAIR-O

Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer

Status unknown NA Last updated 9 March 2020

What this trial tests

NA trial testing Functional Geriatric Assessment in Ovarian Cancer in 120 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	120
Start date	1 June 2020
Primary completion	1 December 2021
Estimated completion	1 December 2022

Drugs / interventions tested

• Functional Geriatric Assessment

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Chemotherapy — all drugs for Chemotherapy →
• Quality of Life — all drugs for Quality of Life →
• Tolerance — all drugs for Tolerance →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

70 and older, female only, with Ovarian Cancer or Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ovarian cancer is frequently diagnosed in older women, with over half of all new diagnoses being in women over 65 years. Current treatment options are based on the results of clinical trials that often do not include older, less fit patients in whom treatments may be less well tolerated. Further, in older patients the impact of complex medical and social issues is not known. The UK lags behind Europe and the United States in the development of research programs dedicated to improving outcomes for older patients. More research focus is urgently required to improve the assessment and management of older women with ovarian cancer to improve survival outcomes, quality of life and functional independence.

Current treatment decisions are made predominantly on age and fitness. However, it has been shown that undertaking a holistic, geriatric assessment of older patients can highlight important issues that would not necessarily be identified in a routine oncology appointment. In this study, we propose to ask oncology teams to undertake a geriatric assessment and specifically address issues that may arise as a result of this. The assessment comprises 8 simple non-invasive assessments that can be performed in the out-patient setting.

This approach could result in an important change in clinical practice leading to more holistic assessment of older cancer patients and better address their specific needs and manage their cancer treatment. The long-term goal is to show that pro-actively managing potential issues at the beginning of treatment allows patients to tolerate treatment and maintain their functional independence, leading to improved quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Under-Treatment of Older Patients with Newly Diagnosed Epithelial Ovarian Cancer Remains an Issue.
   Dumas L, Bowen R, Butler J, Banerjee S. · · 2021 · cited 15× · PMID 33668809 · DOI 10.3390/cancers13050952