Optimising Cardiovascular Health in Endometrial Cancer Survivors
NCT ID: NCT05216913
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2022-02-09
2024-10-31
Brief Summary
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Detailed Description
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The blood tests will screen for diabetes and non-diabetic hyperglycaemia (HbA1c), renal impairment (full blood count- FBC, urea and electrolytes- U\&E), non-alcoholic fatty liver disease and contraindication to statin therapy (liver function tests- LFT), hypercholesterolaemia (total, HDL and LDL cholesterol) and hypothyroidism (thyroid function tests- TFT). Urine samples will be used to screen for renal impairment using dipstick testing for microscopic haematuria and determination of albumin: creatinine ratio (ACR).
An individualised cardiovascular risk assessment will be undertaken using the QRISK3 score, which is assessed by virtue of the presence or absence of individual cardiovascular risk factors.
Based on these findings, an individualised management plan will be generated and appropriate treatment for any modifiable risk factors commenced in accordance with NICE (National Institute for Health and Care Excellence) and local guidelines. This will include advice and support with lifestyle modification, commencing medication if needed and referral to community or specialist clinics. This will be carried with close communication and in conjunction with the patient's general practitioner (GP).
Women will be followed up over a one year period to monitor their response and compliance to treatment and the impact this has on their quality of life.
The quality of life assessments will be undertaken by a member of the research team using the generic 36-Item Short Form Survey \[SF-36\] and cancer-specific Quality of Life in Adult Cancer Survivors \[QLACS\] questionnaires. A subset of approximately twenty women, purposively sampled to include maximal variation in age, body mass index and time from diagnosis, will be selected to participate in a qualitative study of the barriers to the implementation and adherence of lifestyle interventions.
Study visits will be timed to coincide with routine follow-up appointments or be carried out remotely by telephone or Zoom to minimise the risk of COVID-19 exposure. Follow-up visits will consist of a focused interview and quality of life questionnaires, with a repeat of the comprehensive cardiovascular risk assessment at 12 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endometrial cancer survivors
Lifestyle modification
Could include all/some of the following: weight loss, increased physical activity, smoking cessation and reduction in alcohol intake
Cardiovascular Agents, Other
Could include all/some of the following: statins, antihypertensives, diabetic medication, levothyroxine
QRISK 3 Score
Could include a combination of lifestyle measures and/or cardiovascular agents as described above
Interventions
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Lifestyle modification
Could include all/some of the following: weight loss, increased physical activity, smoking cessation and reduction in alcohol intake
Cardiovascular Agents, Other
Could include all/some of the following: statins, antihypertensives, diabetic medication, levothyroxine
QRISK 3 Score
Could include a combination of lifestyle measures and/or cardiovascular agents as described above
Eligibility Criteria
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Inclusion Criteria
* Able to consent to participation in the study
Exclusion Criteria
* Anticipated life expectancy \<12 months
* To cease routine surveillance in next 12 months
* Not registered with a General Practitioner (GP)
18 Years
110 Years
FEMALE
No
Sponsors
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University of Manchester
OTHER
Responsible Party
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Emma Crosbie
Professor
Principal Investigators
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Emma Crosbie
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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St Mary's Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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IRAS 298610
Identifier Type: -
Identifier Source: org_study_id
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