Ovarian CancerFAIR-ONCT04300699
Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer
A study testing Functional Geriatric Assessment in people with Ovarian Cancer and Chemotherapy, run by Royal Marsden NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Chemotherapy, Quality of Life
- What is being tested?
- Functional Geriatric Assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of Frailty Assessment and Implementation of Protocol-led Geriatric Interventions in Women Over the Age of 70 With Epithelial Ovarian Cancer in the Oncology Clinic (FAIR-O)
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.
Read the 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):
- First-line cohort: patients with newly diagnosed advanced (stage III/IV) ovarian cancer who have received no prior treatment for ovarian cancer including surgery.
- 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
- Being tested
- Functional Geriatric Assessment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Geriatric AssessmentOther
A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients over 70 years receiving chemotherapy | Other | 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. Receives: Other: Functional Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Obtained at Baseline (Date of Consent)
Secondary outcomes (8)
Proportion of patients with deficits identified resulting in algorithm defined interventions
The number of deficits identified through use of the Functional Geriatric Assessment resulting in algorithm defined interventions including clinical referrals or assessments as identified during the first oncology clinic visit.
Measured: Obtained at Baseline (Date of Consent)
Proportion of patients developing sarcopenia during chemotherapy treatment, amounting to an average of 6 months on chemotherapy treatment.
The number of patients assessed as sarcopenic as assessed via routine computerized tomography scans conducted at baseline, mid-treatment and the end of treatment.
Measured: 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
The number of patients experiencing Grade 3 or 4 hematological and non-hematological toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) assessed through chemotherapy treatment from the start of treatment, mid-way through treatment and at the end of treatment, an average time-frame of 6 months.
Measured: Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Time on chemotherapy treatment
The length of time in months and days that the patient remains on routine chemotherapy treatment, an average of 6 months.
Measured: Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.
Quality of Life Outcome score in Cancer Patients
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. Maximum (worst) score: 112 and minimum (best) score: 28
Measured: 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.
Quality of Life Outcome score in Ovarian Cancer Patients
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire in Ovarian Cancer Patients (QLQ OV) 28. Maximum (worst) score: 112 and minimum (best) score: 28
Measured: 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.
Quality of Life Outcome score in Elderly Cancer Patients
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire in Elderly Cancer Patients (QLQ ELD) 14. Maximum (worst) score: 56 and minimum (best) score: 14
Measured: 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.
Sarcopenia and frailty
Sensitivity and specificity of sarcopenia in identifying frailty as identified by the Functional Geriatric Assessment
Measured: Assessed between baseline (date of Consent) mid-way though chemotherapy treatment to the date of delivery of last chemotherapy treatment, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort intervention design with 12 month follow-up.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana Banerjee, MBBS MA FRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300699
- Sponsor's protocol ID
- CCR 5138
- Other IDs
- RG2165
- Acronym
- FAIR-O
- Status last verified
- Nov 2019
- First submitted
- 2 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Frailty Assessment and Implementation of Protocol-led Geriatric Interventions in Women Over the Age of 70 With Epithelial Ovarian Cancer in the Oncology Clinic (FAIR-O)
- ClinicalTrials.gov ID
- NCT04300699
- Acronym / sponsor ID
- FAIR-O / CCR 5138
- Conditions
- Ovarian Cancer, Chemotherapy, Quality of Life, Tolerance, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- First-line cohort: patients with newly diagnosed advanced (stage III/IV) ovarian cancer who have received no prior treatment for ovarian cancer including surgery.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort intervention design with 12 month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients over 70 years receiving chemotherapy | Other | Other: Functional Geriatric AssessmentPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Geriatric AssessmentA series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments. | Other | Ovarian cancer patients over 70 years receiving chemotherapy |
Primary outcome
Feasibility of completing the Functional Geriatric Assessment
Time frame: Obtained at Baseline (Date of Consent)
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.
8 secondary outcomes
Proportion of patients with deficits identified resulting in algorithm defined interventions
Time frame: Obtained at Baseline (Date of Consent)
Proportion of patients developing sarcopenia during chemotherapy treatment, amounting to an average of 6 months on chemotherapy treatment.
Time frame: 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
Time frame: Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Time on chemotherapy treatment
Time frame: Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.
Quality of Life Outcome score in Cancer Patients
Time frame: 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.
Quality of Life Outcome score in Ovarian Cancer Patients
Time frame: 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.
Quality of Life Outcome score in Elderly Cancer Patients
Time frame: 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.
Sarcopenia and frailty
Time frame: Assessed between baseline (date of Consent) mid-way though chemotherapy treatment to the date of delivery of last chemotherapy treatment, an average of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Banerjee, MBBS MA FRCP principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Functional Geriatric Assessment in people with Ovarian Cancer and Chemotherapy, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda J Wedlake, PhD (+44 208 915 6768, linda.wedlake@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of completing the Functional Geriatric Assessment (time frame: Obtained at Baseline (Date of Consent)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.