High Risk Patients

Individual risk stratification of prostate cancer screening

The high incidence, a generally long natural history and good chances for curative treatment in case of early detection make prostate cancer ideal for screening. Randomized controlled screening trials have shown that systematic screening with prostate-specific antigen (PSA) significantly reduces prostate cancer mortality.

However, PSA screening is problematic since it leads to diagnosis of a significant proportion of tumors that would not have caused symptoms or death during the man's lifetime. Systematic PSA screening of the general population is therefore not recommended due to unacceptable overdiagnosis and overtreatment.

The aim of the study is to facilitate establishment of an individualized risk stratified prostate cancer screening procedure to identify men at high risk of prostate cancer progression and death who are eligible for clinical work-up.

A combination of biological and genetic markers may contribute to a better prediction of subsequent prostate cancer risk and outcome than PSA alone, and therefore contribute to an efficient screening procedure with high sensitivity and specificity for aggressive prostate cancer. Individually risk stratified screening would facilitate that men at high risk of aggressive prostate cancer and death could be diagnosed in early stages and thus improve their prognosis. Furthermore, fewer men would be enrolled in active surveillance and thereby decrease the need for repeated testing and biopsies and fewer would unnecessarily undergo surgery or radiation therapy for localized disease.

The PACO project. A randomized clinical study of a Patient Coach program in vulnerable lung cancer patients

We have shown that having short education or living without a partner negatively influences lung cancer survival and that low social position is associated with higher risk of advanced stage of the lung cancer at diagnosis.

Differences in stage, treatment of comorbidity at diagnosis explain most of the social inequality in lung cancer survival. In order to reduce social inequality in lung cancer survival not only early detection should be improved but also efforts to ensure optimal treatment among lung cancer patients with low social position are needed.

The purpose of project PACO is to test in a randomized trial whether assigning a patient coach to vulnerable lung cancer patients may help patients to receive the most optimal treatment by empowering patients to participate actively in the treatment decision process and help them navigate the health care system while undergoing treatment.

Project PACO is conducted by the Survivorship Unit, Danish Cancer Society Research Center in collaboration with the lung cancer team at Department of Oncology, Herlev Hospital.

Expected start of Project PACO is January 2016.

Preventive intervention against lymphedema after breast cancer surgery

Lymphedema is a well-known and dreaded complication after treatment for breast cancer, and treatment consists of compression garments and specialized physiotherapy, but there is no cure.

Some studies suggest strengthening exercises can help to prevent lymphedema, and we intend to evaluate in a randomized trial, whether a program of 20 week supervised and 32 weeks home exercise program with progressive strength exercise, can reduce the incidence of lymphedema after breast cancer treatment.

In a an explorative part of the study, we will offer a course of Hyperbaric Oxygen Treatment (HBOT) to those women who do present with lymphedema, to examine if this can further reduce lymphedema.

The study is planned to start in September 2015 and to be completed in 2017.

The WebCan project. Use of computer-based patient-reported data to assess long term and late effects of head and neck cancer at the point of care

Head and neck cancer have an enormous impact on the patients' wellbeing and quality of life due to the numerous physical and psychological adverse effects of the illness and the treatment.

The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients.

The assessment tool is a short questionnaire with questions about cancer related symptoms and psychological wellbeing, which is to be filled out by the patient in the patient waiting area and where the treating physician has direct access to the data in the subsequent consultation.

The MyHealth project

For several years, follow-up after cancer treatment has been calendar-driven with the purpose of detecting recurrence or metastasis of the disease. Recent studies have now shown that for certain cancer types, very few recurrences are detected at the planned follow-up consultations, and that the patients often detect recurrences themselves.

With the MyHealth project, we want to develop and test a new follow-up program for patients treated for breast cancer and head and neck cancer. The overall idea is that the follow-up is based on patients’ symptoms and needs to a greater extent.

In MyHealth, the follow-up will be led by specially trained nurses. The core elements in MyHealth are:

• patient education with focus on specific symptoms that patients should react to
• symptom registrations
• and on basis of these, referral to oncologist or other health professional. 

The overall aim is to prepare the patients to manage their own health after the cancer treatment, and enable them to be aware of, and register, symptoms of recurrence and late effects after the treatment.

In this study, we will compare the MyHealth follow-up program with standard care and examine whether MyHealth improves patients’ ability to register and react on symptoms of recurrence, and handle the physical and psychological late effects after disease and treatment. This will further result in a more efficient use of the health care system.

Patterns in detection of recurrence among women treated for breast cancer

The primary purpose of the follow-up after breast cancer treatment is to detect recurrences and new primary cancer, and to manage symptoms following cancer treatment. Existing guidelines on follow-up programs are based on scarce evidence, though, and there is a need to optimize these in order to secure high quality follow-up after breast cancer treatment.

The aim of the study is to evaluate patterns in detection of recurrence among women treated for breast cancer. We will do this by investigating how the recurrences are detected, if they are asymptomatic or symptomatic, and which alarm symptoms women with symptomatic recurrence report.

The study will be conducted as a cross-sectional survey and data will be retrieved from hospital records, national registries and clinical databases.We will ask for permission to obtain these data among all women who are followed after recurrence of breast cancer at the Departments of Oncology at Aarhus University Hospital and Copenhagen University Hospital.

The study will provide evidence to illustrate the role of the women in their own ability to react to alarm symptoms. Furthermore, it will systematically document the patterns of detection of breast cancer recurrence. Detailed knowledge on this can inform the design of guidelines for follow-up after breast cancer.

The study is a part of the MyHealth study and will be initiated in spring 2016.

Antipsychotic drugs and breast cancer risk: a Nationwide Population-Based Cohort Study in Denmark, 1995-2013

Antipsychotic drugs play an important role in the treatment of several psychiatric disorders. Despite their effectiveness, antipsychotics frequently cause side effects including hyperprolactinemia and metabolic side effects such as diabetes mellitus and weight gain that have been suggested to increase the risk of breast cancer. Anyways, the evidence of a potential adverse carcinogenic effect on breast cancer remains conflicting.

Our study investigate the incidence of breast cancer among the users of antipsychotic medication in a nationwide cohort of breast cancer patients identified from the clinical database Danish Breast Cancer Cooperative Group (DBCG) database during the study period 1995-2013. This cohort will be linked to the National Prescription, the Danish Civil Registration System, the Danish Cancer Registry (information on other cancer) and the Danish Fertility Database.

We suggest to investigate the incidence of breast cancer among users of antipsychotic medication adjusting for use of hormonal treatment, age at first birth and parity, conducting separate analyses by type of antipsychotic, and if sample size allow, to conduct analyses by duration or dose of treatment and also differentiating the outcome into hormone receptor positive or negative.