Clinical trial NCT06429995: Standard Follow-up Program (SFP) for Breast Cancer Patients
Official title: Standard Follow-up Program (SFP) for Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Keywords: Acute toxicity
Late toxicity
Prediction models
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer receiving radiotherapy

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria

Primary outcomes:
measure: Score of Acute toxicity
timeFrame: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
measure: Score of Late toxicity
timeFrame: At one and two years after last day of radiation therapy.
Secondary outcomes:
measure: Overall survival
timeFrame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
measure: Loco-regional tumor control
timeFrame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Other outcomes:
measure: Hemoglobin (Hb)
timeFrame: Before start of radiation therapy
measure: Hematocrit (Ht)
timeFrame: Before start of radiation therapy
measure: Leukocytes
timeFrame: Before start of radiation therapy
measure: Creatinine
timeFrame: Before start of radiation therapy
measure: Estimated Glomerular filtration rate (eGFR)
timeFrame: Before start of radiation therapy
measure: Urea
timeFrame: Before start of radiation therapy
measure: Hemoglobin A1c (HbA1c)
timeFrame: Before start of radiation therapy
measure: Cholesterol
timeFrame: Before start of radiation therapy
measure: High-densitiy-lipoprotein cholesterol (HDL cholesterol)
timeFrame: Before start of radiation therapy
measure: Low-density-lipoprotein cholesterol (LDL cholesterol)
timeFrame: Before start of radiation therapy
measure: Triglycerides
timeFrame: Before start of radiation therapy
measure: High sensitive C-reactive protein (hsCRP)
timeFrame: Before start of radiation therapy
measure: Thyroid stimulating hormone (TSH)
timeFrame: Before start of radiation therapy, 1 and 2 years after radiation therapy
measure: Free Thyroxine-4 (FT4)
timeFrame: Before start of radiation therapy, 1 and 2 years after radiation therapy
measure: Patient-rated Demographics measured with the baseline questionnaire on Demographics
timeFrame: Before start of radiation therapy
measure: Patient-rated symptoms measured with the EORTC QLQ-BR23
timeFrame: 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
measure: Patient-rated symptoms measured with the BCSCQ
timeFrame: 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.
measure: Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)
timeFrame: Before start of radiation therapy
measure: Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)
timeFrame: 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
measure: Patient-rated symptoms measured with the questionnaire on Performance Status
timeFrame: 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
measure: : Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor
timeFrame: 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
measure: Patient-rated Quality of Life measured with the EORTC QLQ-C30
timeFrame: 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
measure: Patient-rated Quality of Life measured with the EuroQoL-5D_5L
timeFrame: 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
measure: Patient-rated Quality of Life measured with EORTC QLQ-BR23
timeFrame: 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
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: Anne Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.