Breast Cancer
Conditions
Keywords
Outpatient clinic, Breast cancer, Late toxicity
Brief summary
In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed. There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival. The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home. The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.
Interventions
OTHEROutpatient clinic
The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.
Sponsors
Maastricht Radiation Oncology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive. * Consent to invitation letter and willing to participate.
Exclusion criteria
* Treatment without curative intent. * No consent to invitation letter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy. | One assessment approximately 10 years after radiotherapy | As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \[Barnett et al, 2012\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity. | One assessment approximately 10 years after radiotherapy | The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4. |
Other
| Measure | Time frame | Description |
|---|---|---|
| In addition, we will record potential risk factors for the several outcome parameters | one consultation by physician (assistant) ten years after radiotherapy | The following the potential risk factors are recorded: 1. Patient related risk factors: * Age at time of diagnosis * Genetic and protein profile blood samples (optional with informed consent of participant) * Smoking 2. Treatment related factors: * Type of surgery * Excision volume * Post-operative complications * Resection margins Free * Scar visibility * Axillary surgery * Radiotherapy * Fractionation scheme * Target volumes * Dose-volume parameters * Actually delivered dose * Chemotherapy * Hormonal treatment * Immunotherapy 3. Tumor related factors * Localization * Stage * Differentiation grade * Hormonal receptors * HER-2 * Genetic profile |
Countries
Netherlands
Outcome results
None listed