Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Limburg
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Maastricht, Limburg, Nederland, 6200 XW
- Maastro Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Outpatient clinic
All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic.
These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome.
In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment.
Patients are seen by a physician or a physician assistant at the outpatient clinic.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
Tijdsspanne: One assessment approximately 10 years after radiotherapy
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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].
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One assessment approximately 10 years after radiotherapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
Tijdsspanne: One assessment approximately 10 years after radiotherapy
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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.
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One assessment approximately 10 years after radiotherapy
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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In addition, we will record potential risk factors for the several outcome parameters
Tijdsspanne: one consultation by physician (assistant) ten years after radiotherapy
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The following the potential risk factors are recorded:
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one consultation by physician (assistant) ten years after radiotherapy
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Liesbeth J Boersma, M.D., Ph.D., Maastro Clinic, The Netherlands
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-25-15/08
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