Three-Dimensional Ultrasound Volume Ratio for Improving Cosmetic Results in Breast Cancer Patients; TURACOS trial

The expected cosmetic result plays an important role in the decision between
mastectomy and breast conserving surgery (possibly in combination with plastic
surgical reconstructive techniques) in breast cancer patients. Moreover,
cosmetic results influenes patient satisfactior and quality of life. Therefore,
it is important to pay attention to the cosmetic result without having to make
concessions on the oncological result. Still, on average 15% of the breast
conserving surgeries (BCS) are irradical and reoperation is needed. Therefore,
in current practice the result of BCS is not always satisfying for patient and
medical proffesional. To be able to anticipate on inferior cosmetic result, the
surgeon needs a tool to predict the cosmetic result. This would make it
possible to adequately inform the patient, aid in treatment decision making and
create realistic expectations which result in potentially more patient
satisfaction and quality of life. We have performed a retrospective study to
volume measurements of tumor in relation to the breast and it's influence on
cosmetic result after BCS. It showed that a larger Tumor Volume / Breast Volume
(Volume Ratio) resulted in 1) worse cosmetic result, 2) less patient
satisfaction, and 3) more irradicality. Consequently, we decided to study this
volume ratio as part of preoperative workup, which has never been done before.

The value of implementation and cost-efficacy of Tumor Volume / Breast Volume
Ratio, as measured by Automated Breast Volume Scanner (ABVS), during the
preoperative workup in breast cancer patients on 1) cosmetic result after BCS,
and 2) surgical procedure performed, pathological result, patient satisfaction
and quality of life.

The study desgin is an open, randomized and controlled clinical trial. Patients
in the control group will receive standard peroperative workup with an
additional ABVS Volume Ratio. The Volume Ratio will be blinded for alle
participants and by that will not influence treatment decision making. The
Volume Ratio in the intervention group will be inserted in the predicition
model. The prediction will be encounted for the treatment decision making by
multidiciplinary consultation and influence treatment advice given.

All patients will undergo the Automated Breast Volume Scanner (ABVS) at the
department of radiology, Erasmus MC Cancer Institute. Tumor Volume and Breast
Volume will be measured and a Volume Ratio will be calculated as following:
Tumor Volume / Breast Volume Ratio * 1000. Both patients in the control- and
intervention arm receive standard preoperative workup which includes the
multidisciplinary preoperative consultation who devises a treatment plan. If
chosen for BCS, there is the possibility of doing a combined oncological- and
plastic surgical procedure (oncoplastic surgery) with breast lift- and breast
reduction techniques. For patients in the intervention arm, their Volume Ratio
will be taken into consideration by devising the treatment plan advice. The
advice is given to the patient by the treating surgeon, but the final treatment
decision is made by patients. Both patients in the control- and intervention
arm will receive three questionnaires preoperatively; 1) EORTC/EQ-5D-5L quality
of life questionnaires, and 2) about the expectations regarding cosmetic result
(BREAST-Q). Pre- and postoperatively (1 and 3 year after initial operation) the
professional medical photographer will take three pictures of the breast
(between collar bone and umbilicus). Postoperative photos will be used for
panel and assymetry evaluations. At a follow-up visit again three
questionnaires are supposed to be filled in: 1) EORTC/EQ-5D-5L quality of life
questionnaires and 2) concercing cosmetic result (BREAST-Q).

Minor risks are associated to participation in this study. Minimal burden to
the patient is caused by 1) undergoing the Automated Breast Volume Scanner
(ABVS) for 10 minutes, 2) visit to the medical photographer for 5 minutes, and
3) answering three questionnaires five times; two concering quality of life
questionnaires (EORTC/EQ-5D-5L) and one concerning cosmesis (BREAST-Q), which
takes 15 minutes in total. Almost all (if not all) interventions will be
planned immediately following other visits at the Erasmus MC Cancer Institute.
The EORTC/EQ-5D-5L quality of life questionnaire is extensively validated and
the questionnaire concering cosmesis has been used by us in previous studies
and has not been found burdensome to the patients. Attached to the
questionnaires, contact information for the psychosocial support team will be
given who can be contacted any time the patient feels uncomfortable with the
questions asked and feels she wants to talk about it.