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

NCT ID: NCT04300699

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-12-01

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.

Detailed Description

FAIR-O is a single-arm, multi-center, phase II intervention trial of a geriatric assessment in older patients (≥ 70 years old) diagnosed with epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients will be approached if they are being considered for systemic chemotherapy either as neoadjuvant / front-line chemotherapy in the first-line setting OR for chemotherapy at first relapse.

Two cohorts of patients will be recruited and run in parallel (no comparison will be performed between them):

1. First-line cohort: patients with newly diagnosed advanced (stage III/IV) ovarian cancer who have received no prior treatment for ovarian cancer including surgery.

2. First relapse cohort: ovarian cancer patients with first relapse

On consenting to the trial, a comprehensive medical and treatment history will be obtained including blood tests, tumour markers and a CT scan. The CT scan will be assessed for extent (volume) of muscle mass and compared to reference standards to identify patients with low muscle attenuation and sarcopenia (i.e. loss of muscle mass).

In addition, consented patients will be asked to undertake a comprehensive Geriatric Assessment which comprises a collection of 8 tests - all of which are non-invasive. These test comprise validated questionnaires and functional assessments including the G8 questionnaire, independent activities of daily living (IADL), activities of daily living (ADL), Charlson co-morbidity score, Hospital anxiety and depression scale (HADS), mini nutritional assessment (MNA), a timed up-and-go test and a mini cognitive assessment.

The Geriatric Assessment will enable the treating clinical team to determine whether the patient has specific deficits or problems which need further specialist attention with the aim of ensuring maximum tolerance to chemotherapy treatment. A Study Algorithm will guide the clinician to the most appropriate actions. These actions may include referral to other specialist services or referral for specific diagnostic tests. The number and type of referrals and the time taken for that referral to be performed will be captured.

Following the initial assessment in clinic, patients will will continue to attend standard treatment chemotherapy clinics. Their response to treatment will be recorded including the emergence of symptoms of study interest. Throughout the study decisions regarding systemic chemotherapy including regimen choice, dose modifications and supportive medications will be the responsibility of the treating oncologist and will not be determined by the outcome of the Geriatric Assessment.

Patients will be recruited until 60 patients have been recruited to each cohort. Patients will be followed-up until the end of the study which will be defined as 12 months from study entry or disease progression or death, whichever comes soonest.

The feasibility of introducing the Geriatric Assessment into the standard of care chemotherapy pathway is the primary end point of the study and will be statistically assessed. The number of fully completed assessments that the Research Team are able to conduct in the predicted target of 120 patients recruited to the trial will determine the feasibility on introducing the Geriatric Assessment to routine oncology clinics for this patient cohort.

Conditions

Ovarian Cancer; Chemotherapy; Quality of Life; Tolerance; Aged

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ovarian cancer patients over 70 years receiving chemotherapy

Patients 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.

Group Type: OTHER

Functional Geriatric Assessment

Intervention Type: OTHER

A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.

Interventions

Functional Geriatric Assessment

A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana Banerjee, MBBS MA FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Central Contacts

Linda J Wedlake, PhD

Role: CONTACT

linda.wedlake@rmh.nhs.uk

+44 208 915 6768

Sarah R Webb, BA

Role: CONTACT

sarah.webb2@rmh.nhs.uk

+44 208 915 6508

Other Identifiers

RG2165

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CCR 5138

Identifier Type: -

Identifier Source: org_study_id