Clinical trial NCT01978756: Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.
Official title: Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Outpatient clinic
Breast cancer
Late toxicity
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 387
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are all patients who have been treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003. They will be retrieved from the appointment -IT system. For all these patients will be checked whether they are alive using the MBA (municipal base administration).

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.
timeFrame: One assessment approximately 10 years after radiotherapy
Secondary outcomes:
measure: The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.
timeFrame: One assessment approximately 10 years after radiotherapy
Other outcomes:
measure: In addition, we will record potential risk factors for the several outcome parameters
timeFrame: one consultation by physician (assistant) ten years after radiotherapy
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
state: Limburg
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Liesbeth J Boersma, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: