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

Completed

• Conditions: Breast Cancer
• Interventions: Other: Outpatient clinic

• Registration Number: NCT01978756
• Lead Sponsor: Maastricht Radiation Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 387

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatient clinic	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

MAASTRO clinic; 🇳🇱 Maastricht, Limburg, Netherlands