Optimising Cardiovascular Health in Endometrial Cancer Survivors

NCT05216913 | Unknown

• 1 other identifier: IRAS 298610
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial Cancer; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 3 months, 6 months and 12 months.

Secondary Outcomes (1)

• To identify barriers to the implementation of lifestyle changes in endometrial cancer survivors.

  Between 3 and 9 months.

Study Arms (1)

Endometrial cancer survivors

Behavioral: Lifestyle modification; Drug: Cardiovascular Agents, Other; Other: QRISK 3 Score

Interventions

Lifestyle modification BEHAVIORAL

Could include all/some of the following: weight loss, increased physical activity, smoking cessation and reduction in alcohol intake

Endometrial cancer survivors

Cardiovascular Agents, Other DRUG

Could include all/some of the following: statins, antihypertensives, diabetic medication, levothyroxine

Endometrial cancer survivors

QRISK 3 Score OTHER

Could include a combination of lifestyle measures and/or cardiovascular agents as described above

Endometrial cancer survivors

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have had endometrial cancer treated within the last 4 years.

You may qualify if:

• Previous treatment for endometrial cancer within the last four years
• Able to consent to participation in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

St Mary's Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Cardiovascular Diseases

Interventions

Cardiovascular Agents

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Emma Crosbie

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 1, 2022
• Study Start: February 9, 2022
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

GB (1)