Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer
FAIR-O
2 other identifiers
interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable ovarian-cancer
Started Jun 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 9, 2020
November 1, 2019
1.5 years
March 2, 2020
March 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of completing the Functional Geriatric Assessment
Proportion of patients in whom it was possible to complete the Functional Geriatric assessment within the Oncology Clinic setting, assessed at the point of the first oncology clinic visit.
Obtained at Baseline (Date of Consent)
Secondary Outcomes (8)
Proportion of patients with deficits identified resulting in algorithm defined interventions
Obtained at Baseline (Date of Consent)
Proportion of patients developing sarcopenia during chemotherapy treatment, amounting to an average of 6 months on chemotherapy treatment.
Baseline (Date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Proportion of patients with grade 3/4 hematological and non-hematological toxicities
Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Time on chemotherapy treatment
Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.
Quality of Life Outcome score in Cancer Patients
Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
- +3 more secondary outcomes
Study Arms (1)
Ovarian cancer patients over 70 years receiving chemotherapy
OTHERPatients with ovarian cancer receiving chemotherapy as either first line treatment (i.e. newly diagnosed advanced stage III/IV cancer) or at first relapse. Patients to receive a Geriatric Assessment including interventions for functional or other identified deficits and appropriate specialist algorithm-determined interventions.
Interventions
A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.
Eligibility Criteria
You may qualify if:
- Age at time of consideration for systemic chemotherapy of 70 years and above
- Histological or cytological confirmation of epithelial ovarian cancer
- Planning to commence systemic chemotherapy for either newly diagnosed epithelial ovarian cancer or first disease relapse
- Life expectancy greater than 3 months
- Able to give informed consent, complete questionnaires in english and comply with study procedures
You may not qualify if:
- In the opinion of the investigator, patient is not fit for systemic chemotherapy or patient declines systemic chemotherapy
- Patient does not have the capacity to consent for enrollment into the study or capacity to consent for systemic chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susana Banerjee, MBBS MA FRCP
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 9, 2020
Study Start
June 1, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
March 9, 2020
Record last verified: 2019-11