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Clinical Trial 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.


Clinical Trial Description

Breast cancer is the most common malignancy diagnosed in women, after non-melanoma skin cancer. More than 80% of the women currently diagnosed with breast cancer are expected to be alive in five years. However, breast cancer is perceived as a life-threatening disease and its diagnosis may be a major source of distress for patients. The treatments for breast cancer often have a profound impact in the women physical and psychological health; for example, many women develop fatigue during the treatment period and this may linger afterwards. In the period after acute treatment, women in remission from their cancer might fear cancer recurrence and death, and worry about the impact of their diagnosis on their family, including children and spouse. The aforementioned factors may impact the quality of life and mental health of the breast cancer survivors.

Population-based studies evaluating health-related quality of life, and the severity of anxiety and depressive symptoms, in samples of breast cancer survivors have been scare, and it is currently unknown how measures of these outcomes differ compared with women who did not have cancer. With this study, we aim to assess the health related quality of life, 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.

Health-related quality of life will be assessed using the Quality of Life in Adult Cancer Survivors Scale (QLACS) (Avis, 2005). This scale includes several general and cancer-specific domains; items in general domains are applicable to all women, while women who have had breast cancer will also answer to cancer-specific items. This scale was developed to take into account the specific needs that cancer survivors experience during the survivorship period. Depressive and anxiety symptoms will be assessed with the Hospital Anxiety and Depression Scale (HADS). This scale has been widely used in samples of the general population as well as hospitalized patients, as it excludes somatic symptoms of anxiety and depression that may be disease manifestations. The scale then uses cut-off points to identify patients who are likely to have clinically relevant symptoms of depression and anxiety.

Participants will be selected from The Clinical Practice Research Datalink (CPRD) primary care database. We will select a random sample of breast cancer survivors (≥1 year), whose general practitioner (GP) agrees to participate in the study, 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 primary care practice. Staff at each practice will mail the study materials to the eligible women, who will complete the questionnaires anonymously and send those to the CPRD Intervention Studies Team for processing.

Participation rates in previous studies of this nature has been very low (20%). 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.

Studies directly recruiting breast cancer survivors have been constrained by the high cost and logistics necessary to recruit the patients and process the data. Therefore, it is of interest to know the feasibility of studying these outcomes using data sources that avoid direct patient involvement. Thus, 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, we will ask each patient's GP to answer to a brief questionnaire that evaluates similar constructs to the questionnaires given to patients. We will also examine the electronic health records of the participants, which may contain data on symptoms and diagnoses that could be used to study the outcomes of interest. We will compare the information from these three sources of data (data directly reported by the patient, data reported by the patients' GPs and data stored in the patients' EHR) to assess the feasibility of studying patient reported outcomes using data sources which do not require direct patient involvement. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03307291
Study type Observational
Source London School of Hygiene and Tropical Medicine
Contact Helena Carreira, MSc
Phone +44 (0) 20 7636 4754
Email helena.carreira@lshtm.ac.uk
Status Not yet recruiting
Phase N/A
Start date December 2017
Completion date December 2018

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