Risk of adverse mental health outcomes in women with a history of breast cancer in the United Kingdom: a population-based matched cohort study

Study type
Protocol
Date of Approval
Study reference ID
18_253
Lay Summary

Women with a history of breast cancer are the largest group of cancer survivors in the general population. A breast cancer diagnosis may impact on mental health, and breast cancer treatments, which are necessary to control the disease, can result in side effects that may negatively affect the women's quality of life. This study aims to understand whether women who have had breast cancer have different mental health several years post-treatment, compared to women who did not have cancer. For this, we will compare the risk of being diagnosed with anxiety and depression, the primary outcomes of this study, in women who have had breast cancer and in women who never had cancer, attending general practitioner (GP) practices in the UK. We will also compare GP recorded declines in the patients' memory and thinking capacities, feelings of tiredness and weakness (fatigue), pain, insomnia, sexual problems, or self-harm and suicide (secondary outcomes), between the two groups, and explore factors that may be associated with increased risk of these outcomes. The results of this study can be used to better understand the needs of the women who carry on lives beyond breast cancer.

Technical Summary

The aim of this study is to estimate the relative risk of anxiety and depression (primary outcomes), and fatigue, pain, sleep disorders, neurocognitive and sexual dysfunctions, and fatal and non-fatal self-harm (secondary outcomes), in breast cancer survivors compared to non-cancer controls. This study will be a matched cohort study, utilising data from the CPRD GOLD primary care database. Outcome-specific algorithms will be developed and validated to ascertain outcomes in the data. Algorithm development will consider Read codes for diagnoses, prescriptions, referrals and symptoms; prevalence and incidence estimates by age-group and sex will be computed for a random sample of patients selected from CPRD GOLD primary care database. Validation will be against external sources of data, namely published data from population-based surveys in the UK. To estimate the associations between breast cancer survivorship and the primary and secondary outcomes, we will ascertain all women exposed to breast cancer in the CPRD GOLD primary care database, and randomly select an age- and primary-care-practice-matched cohort of women without prior cancer in a ratio of 1:4. Cox regression models will be used to estimate hazard ratios adjusted for important confounders, and to explore the role of effect modifiers; the proportionality of hazards will be tested graphically and inferentially.

Health Outcomes to be Measured

• Anxiety
• Depression
• Fatigue
• Cognitive impairment
• Pain
• Sexual dysfunction
• Sleep disorders
• Completed suicide
• Self-harm

Collaborators

Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Esha Abrol - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachael Williams - Collaborator - CPRD
Susannah Stanway - Collaborator - Royal Marsden Hospital

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation