Breast Cancer Clinical Trial
Official 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
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.
Status | Not yet recruiting |
Enrollment | 900 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria for women who have had a breast cancer: - Registered with a primary care practice actively contributing with data of acceptable quality for research to the Clinical Practice Research Datalink; - At least one year of registration with the primary care practice prior to the index date; - Age between 18 to 80 years; - Vital status alive at the time of the study recruitment; - A breast cancer diagnosed one year or more before the start date of the study. Inclusion criteria for women who did not have cancer: - Registered with a primary care practice actively contributing with data of acceptable quality for research to the Clinical Practice Research Datalink; - At least one year of registration with the primary care practice prior to the index date; - Age between 18 to 80 years; - Vital status alive at the time of the study recruitment; - Never had been diagnosed with a cancer. Exclusion criteria: - The woman is considered unable to complete a self-administered questionnaire written in English for any reason. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Clinical Practice Research Datalink |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-related quality of life | The difference of the mean or median score (as appropriate depending on the distribution of the data) of the generic domains of health-related quality of life, measured with the Quality of Life in Adult Cancer Survivors Scale, between breast cancer survivors and women who never had cancer. | One year or longer after breast cancer diagnosis for women who have had breast cancer | |
Secondary | Mean scores of depressive symptoms | The difference in the mean score of depressive symptoms, as measured by the Hospital Anxiety and Depression Scale, between breast cancer survivors and women who did not have cancer. | One year or longer after breast cancer diagnosis for women who have had breast cancer | |
Secondary | Mean scores of anxiety symptoms | The difference in the mean score of anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale, between breast cancer survivors and women who did not have cancer. | One year or longer after breast cancer diagnosis for women who have had breast cancer |
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