Mental health and quality of life in women who have had breast cancer
Research type
Research Study
Full title
Mental health and quality of life of female breast cancer survivors compared to women who did not have cancer, and feasibility of using electronic health records’ data to study patient reported outcomes
IRAS ID
224561
Contact name
Helena I M Carreira
Contact email
Sponsor organisation
London School of Hygiene & Tropical Medicine
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
We aim to assess the quality of life (QoL), and presence and severity of anxiety and depressive symptoms, in women who have had breast cancer diagnosed at ≥1 year, compared to women who did not have cancer.
The Clinical Practice Research Datalink (CPRD) primary care database will be used to select a random sample of breast cancer survivors (≥1 year), whose general practitioner (GP) agrees to participate in the study (see below), and who were registered with the practice for ≥1 year before and after the breast cancer diagnosis. Age-matched women who never had cancer will be randomly selected from the same practice. Staff at each practice will mail the study materials to the eligible women, who will complete the questionnaires and send those to the CPRD Intervention Studies Team for processing.
Studies of patient reported outcomes (PROs) have been limited by the high cost, time and logistics involved in recruiting patients and processing data. We will evaluate the feasibility of collecting these data using electronic questionnaires rather than paper ones. Thus, nearly half of the participants will receive paper questionnaires, while the others will receive instructions on how to complete the questionnaires online. We will compare the participation rate by each method.In addition, a secondary objective of this study is to assess whether PROs can be reasonably studied by using electronic health records (EHR) or by inquiring the patients’ GP, as any of these would involve fewer resources. For this, the EHR of the participating women will be collated from the CPRD primary care database, and the GPs of the participating women will report on their awareness of the patient’s anxiety and depressive disorders, or distress for QoL domains; the results of the two sources will be compared to those reported by the patients.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0403
Date of REC Opinion
24 Nov 2017
REC opinion
Further Information Favourable Opinion