Standard Follow-up Program (SFP) for Breast Cancer Patients (SFPMAMMA)

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.

Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer receiving radiotherapy

Description

Inclusion Criteria:

• Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria:

• Failure to comply with any of the inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of Acute toxicity	Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).	Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
Score of Late toxicity	Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).	At one and two years after last day of radiation therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Loco-regional tumor control	Loco-regional tumor control	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (Hb)	Hb level (mmol/l) measured in blood	Before start of radiation therapy
Hematocrit (Ht)	Ht levels (L/L) measured in blood	Before start of radiation therapy
Leukocytes	Leukocytes + differential count (10E9/l) measured in blood	Before start of radiation therapy
Creatinine	Creatinine levels (mmol/l) measured in blood	Before start of radiation therapy
Estimated Glomerular filtration rate (eGFR)	eGFR calculated from creatinine levels (ml/min)	Before start of radiation therapy
Urea	Urea levels (mmol/l) measured in blood	Before start of radiation therapy
Hemoglobin A1c (HbA1c)	HbA1c levels (mmol/mol) measured in blood	Before start of radiation therapy
Cholesterol	Cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
High-densitiy-lipoprotein cholesterol (HDL cholesterol)	HDL cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
Low-density-lipoprotein cholesterol (LDL cholesterol)	LDL cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
Triglycerides	Triglycerides levels (mmol/L) measured in blood	Before start of radiation therapy
High sensitive C-reactive protein (hsCRP)	HsCRP levels (mg/L) measured in blood	Before start of radiation therapy
Thyroid stimulating hormone (TSH)	TSH levels (mU/L) measured in blood	Before start of radiation therapy, 1 and 2 years after radiation therapy
Free Thyroxine-4 (FT4)	FT4 levels (pmol/L) measured in blood	Before start of radiation therapy, 1 and 2 years after radiation therapy
Patient-rated Demographics measured with the baseline questionnaire on Demographics	Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)	Before start of radiation therapy
Patient-rated symptoms measured with the EORTC QLQ-BR23	Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Patient-rated symptoms measured with the BCSCQ	Patient-rated symptoms are measured with the Breast Cancer Questionnaire (BCSCQ: Based on the BCTOS (1) and the questionnaire on Patients' satisfaction with the cosmetic outcome by Sneeuw at al.(2))	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years.
Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)	Patient-rated symptoms are measured with the baseline questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases before start of radiation therapy (unvalidated questionnaire)	Before start of radiation therapy
Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)	Patient-rated symptoms are measured with the follow up questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (semi)annually after last day of radiation therapy (unvalidated questionnaire)	6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Patient-rated symptoms measured with the questionnaire on Performance Status	Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
: Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor	Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)	6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Patient-rated Quality of Life measured with the EORTC QLQ-C30	Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Patient-rated Quality of Life measured with the EuroQoL-5D_5L	Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D_5L)	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Patient-rated Quality of Life measured with EORTC QLQ-BR23	Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).	Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Anne Crijns, MD, PhD, UMCG

Publications and helpful links

General Publications

• Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.
• Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Acute toxicity; Late toxicity; Prediction models
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SFP MAMMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No