Endometrial CancerOPTIMUSNCT05216913
Optimising Cardiovascular Health in Endometrial Cancer Survivors
An observational study of Endometrial Cancer and Cardiovascular Diseases, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Women successfully treated for endometrial cancer remain at higher risk of dying than women without a history of the disease, predominately due to an excess risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women only
- Conditions the study is for
- Endometrial Cancer, Cardiovascular Diseases
- What is being tested?
- Lifestyle modification, Cardiovascular Agents, Other and QRISK 3 Score
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2022to Oct 2024
- Phase
- Observational
- 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 18 to 110 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have had endometrial cancer treated within the last 4 years.
Who may be able to join
- Previous treatment for endometrial cancer within the last four years
- Able to consent to participation in the study
Who cannot join
- Currently undergoing treatment for endometrial cancer recurrence
- Anticipated life expectancy <12 months
- To cease routine surveillance in next 12 months
- Not registered with a General Practitioner (GP)
Trial locations and contacts
1 site in 1 country.
About this study
Women successfully treated for endometrial cancer remain at higher risk of dying than women without a history of the disease, predominately due to an excess risk of cardiovascular disease. Our previous work has shown that endometrial cancer survivors are more likely to have undiagnosed and undertreated cardiovascular risk factors than the general population, despite being seen regularly by medical professionals. This study aims to determine the impact of optimising modifiable cardiovascular risk factors in endometrial cancer survivors on their quality of life and to identify barriers to lifestyle modifications.
Read the detailed description
A comprehensive cardiovascular risk assessment will be performed as part of clinical care on women previously treated for endometrial cancer at the study site. This will include a focused interview, examination to determine body mass index (BMI) and waist circumference, blood pressure, blood tests and a urine sample.
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
- Endometrial Cancer, Cardiovascular Diseases
- Being tested
- Lifestyle modification, Cardiovascular Agents, Other, QRISK 3 Score
- Medical subject headings
- Endometrial Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Could include all/some of the following: weight loss, increased physical activity, smoking cessation and reduction in alcohol intake
Cardiovascular Agents, OtherDrug
Could include all/some of the following: statins, antihypertensives, diabetic medication, levothyroxine
QRISK 3 ScoreOther
Could include a combination of lifestyle measures and/or cardiovascular agents as described above
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer survivors | Not described Receives: Behavioral: Lifestyle modification; Drug: Cardiovascular Agents, Other; Other: QRISK 3 Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
The generic 36-Item Short Form Survey (SF-36) questionnaire focused on general wellbeing and quality of life.
A variety of responses are used in this questionnaire. Some use numeric indicators, with a lower overall score meaning a worse outcome and a higher score meaning a better outcome.
Measured: Baseline, 3 months, 6 months and 12 months.
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
The cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) questionnaire focused on general well-being and quality of life.
This questionnaire uses numeric indicators from 1 to 7, with a lower overall score meaning a worse outcome and a higher score meaning a better outcome.
Measured: Baseline, 3 months, 6 months and 12 months.
Secondary outcomes (1)
To identify barriers to the implementation of lifestyle changes in endometrial cancer survivors.
A subset of approximately twenty women, will take part in semi-structured interviews to discuss barriers to implementation and adherence to lifestyle interventions. Questioning will focus on the motivations, opportunities and capability of individuals to change their behaviour and will be thematically analysed, with particular attention paid to features of the Behavioural Change Wheel.
Measured: Between 3 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start9 Feb 2022
- Primary completionApr 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Crosbie, University of Manchester
- Investigators
- Emma Crosbie, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216913
- Sponsor's protocol ID
- IRAS 298610
- Acronym
- OPTIMUS
- Status last verified
- May 2023
- First submitted
- 4 Jan 2022
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Cardiovascular Health in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT05216913
- Acronym / sponsor ID
- OPTIMUS / IRAS 298610
- Conditions
- Endometrial Cancer, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Feb 2022 (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.
Women successfully treated for endometrial cancer remain at higher risk of dying than women without a history of the disease, predominately due to an excess risk of cardiovascular disease. Our previous work has shown that endometrial cancer survivors are more likely to have undiagnosed and undertreated cardiovascular risk factors than the general population, despite being seen regularly by medical professionals. This study aims to determine the impact of optimising modifiable cardiovascular risk factors in endometrial cancer survivors on their quality of life and to identify barriers to lifestyle modifications.
Detailed description
A comprehensive cardiovascular risk assessment will be performed as part of clinical care on women previously treated for endometrial cancer at the study site. This will include a focused interview, examination to determine body mass index (BMI) and waist circumference, blood pressure, blood tests and a urine sample.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer survivors | – | Behavioral: Lifestyle modification, Drug: Cardiovascular Agents, Other, Other: QRISK 3 Score |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have had endometrial cancer treated within the last 4 years.
Key inclusion criteria (2 listed)
- Previous treatment for endometrial cancer within the last four years
- Able to consent to participation in the study
Key exclusion criteria (4 listed)
- Currently undergoing treatment for endometrial cancer recurrence
- Anticipated life expectancy <12 months
- To cease routine surveillance in next 12 months
- Not registered with a General Practitioner (GP)
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 |
|---|---|---|
| Lifestyle modificationCould include all/some of the following: weight loss, increased physical activity, smoking cessation and reduction in alcohol intake | Behavioural | Endometrial cancer survivors |
| Cardiovascular Agents, OtherCould include all/some of the following: statins, antihypertensives, diabetic medication, levothyroxine | Drug | Endometrial cancer survivors |
| QRISK 3 ScoreCould include a combination of lifestyle measures and/or cardiovascular agents as described above | Other | Endometrial cancer survivors |
Primary outcome
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
Time frame: Baseline, 3 months, 6 months and 12 months.
The generic 36-Item Short Form Survey (SF-36) questionnaire focused on general wellbeing and quality of life. A variety of responses are used in this questionnaire. Some use numeric indicators, with a lower overall score meaning a worse outcome and a higher score meaning a better outcome.
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
Time frame: Baseline, 3 months, 6 months and 12 months.
The cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) questionnaire focused on general well-being and quality of life. This questionnaire uses numeric indicators from 1 to 7, with a lower overall score meaning a worse outcome and a higher score meaning a better outcome.
1 secondary outcome
To identify barriers to the implementation of lifestyle changes in endometrial cancer survivors.
Time frame: Between 3 and 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Emma Crosbie principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Cardiovascular Diseases, run by University of Manchester at 1 site in United Kingdom.
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 2 inclusion and 4 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months. (time frame: Baseline, 3 months, 6 months and 12 months.). The study lists 2 primary outcomes in all. 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 16 May 2023.