Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

NCT01978756 | Completed

• 1 other identifier: 12-25-15/08
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Outpatient clinic; Breast cancer; Late toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• In addition, we will record potential risk factors for the several outcome parameters

  one consultation by physician (assistant) ten years after radiotherapy

Study Arms (1)

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

Interventions

Outpatient clinic OTHER

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.

Outpatient clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Treatment without curative intent.
• No consent to invitation letter

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6200 XW, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

As part of the study a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank. The purpose to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects. For detailed information: ClinicalTrials.gov Identifier: NCT01084785

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Liesbeth J Boersma, M.D., Ph.D.

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: November 7, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

NL (1)