Frailty and polypharmacy among adults aged 18 and above with cancer at the time of diagnosis

Study type
Protocol
Date of Approval
Study reference ID
24_003796
Lay Summary

Ageing is associated with an increment in vulnerability, also known as fragility, and the diagnosis of long-term conditions. Both can make people less able to cope and recover from physical illness or other stressful events. Long-term conditions require treatments, and the presence of several conditions into the same person leads to people taking several medicines concomitantly, also known as polypharmacy, which is particularly common among the elderly.

People who are diagnosed with a cancer and who are already taking multiple medications or live with frailty, may have a poorer chance of recovery and their treatments options may be limited. This study aims to better understand how common frailty and polypharmacy are among people diagnosed with different cancers, and if being frail has an impact on mortality in patients diagnosed with cancer.

Technical Summary

OBJECTIVE:
The aim of this study requested by the European Medicines Agency is to estimate the prevalence of frailty and polypharmacy at the point of diagnosis of selected cancers in people aged 18 and above and to describe their characteristics.

STUDY POPULATION:
The study population will include all individuals aged 18 years and above with a primary diagnosis of cancer (lung, breast, ovary, endometrium, prostate, pancreas, colorectal cancer, lymphoma, leukemia and myeloma) between 01/01/2017 and 31/12/2022, with at least one year of prior history available in CPRD GOLD before cancer diagnosis. Individuals with a diagnosis of cancer (any, excluding non-melanoma skin cancer) any time prior to the diagnosis of one of the selected cancers will be excluded.

OUTCOME DEFINITIONS:
Polypharmacy will be defined as the concomitant prescription of >= 5 or >= 10 medications (therapeutic groups) anytime during the year prior to cancer diagnosis.
A frailty score will be calculated based on 34 diagnoses (+ polypharmacy) included in well-known frailty indexes (e.g. the eFI) recorded anytime prior or at cancer diagnosis, and will be further categorised into levels of severity: fit, mild frailty, moderate frailty and severe frailty.

STATISTICAL ANALYSES
1) The prevalence of frailty and polypharmacy will be estimated at the time of cancer diagnosis.
2) Summary patient characteristics will be provided at the time of cancer diagnosis, stratified by polypharmacy status and frailty severity
3) Mortality rates will be calculated for up to 365 days after cancer diagnosis
All analyses will be stratified by cancer type and age groups

BENEFIT FOR PATIENTS
Frailty, polypharmacy, and comorbidities are common and can have adverse impact on cancer outcomes and treatment. This study can inform future programs to improve healthcare for cancer patients with frailty and polypharmacy.

Health Outcomes to be Measured

Prevalence of frailty and polypharmacy, descriptive characteristics of people with cancer, 1 year mortality rates

Collaborators

Annika Jodicke - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford