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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Outpatient clinic

• Study Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 XW
      • Maastro clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Outpatient 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the incidence and severity of locoregional late toxicity at 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].	One assessment approximately 10 years after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.	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.	One assessment approximately 10 years after radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In addition, we will record potential risk factors for the several outcome parameters	The following the potential risk factors are recorded: Patient related risk factors:Age at time of diagnosisGenetic and protein profile blood samples (optional with informed consent of participant)Smoking; Treatment related factors:Type of surgeryExcision volumePost-operative complicationsResection margins FreeScar visibilityAxillary surgeryRadiotherapyFractionation schemeTarget volumesDose-volume parametersActually delivered doseChemotherapyHormonal treatmentImmunotherapy; Tumor related factorsLocalizationStageDifferentiation gradeHormonal receptorsHER-2Genetic profile	one consultation by physician (assistant) ten years after radiotherapy

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Investigators: Principal Investigator: Liesbeth J Boersma, M.D., Ph.D., Maastro Clinic, The Netherlands

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: October 31, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Late toxicity; Outpatient clinic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 12-25-15/08