Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

ConditionsBreast Cancer Breast Carcinoma in Situ Breast Cancer Invasive Breast Asymmetry

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUppsala University

About this trial

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged above 18 years.

Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview.

Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS.

ECOG performance status 0-2.

Disqualifiers

Life expectancy of less than 6 months

Non candidate for breast conservation

Inability to understand given information and give informed consent or undergo study procedures

Trial population

As discussed above

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Avoidance of mastectomy

Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that are operated with oncoplastic breast conservation resulting in negative margins and avoid mastectomy.

Time frame

3 months

Re-excision rates

Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that undergo breast conservation, but require re-excision of margins without conversion to mastectomy as a final result.

Time frame

3 months

Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) is a validated 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. It assesses both quality of life domains and symptom domains in a scale score ranging from 0 to 100. For the quality of life domains, higher scores denote higher satisfaction or higher quality of life. For symptom scales, higher score denotes more severe symptoms. In the Summary Score of the Questionnaire, higher values denote higher quality of life

Time frame

Baseline, postoperative (6, 12, 24 months)

Patient reported outcomes, BreastQ module for Satisfaction with Breasts

The BREAST-Q questionnaire is developed especially for breast cancer patients undergoing breast surgery. Independent modules are available for the different surgical interventions (e.g., mastectomy, reconstruction, augmentation). The BREAST-Q questionnaire has been validated and serves as of a standardized measurement instrument. The Satisfaction with Breasts module is summarized in a score ranging from 0 to 100, with higher scores denoting higher satisfaction

Time frame

Baseline, postoperative (6, 12, 24 months)

Secondary outcomes

Postoperative Complications

Postoperative complications, reported descriptively, per the modified Clavien Dindo classification and the Comprehensive Complication Index 2.0 (CCI 2.0)

Time frame

6 weeks or up to 3 months if no other adjuvant oncologic treatment has been employed

Operative time

Operative time in minutes

Time frame

At surgery

Length of stay

Number of days of inpatient care

Time frame

Perioperative

Profile of mastectomy candidates

Characteristics of patients that require mastectomy per surgeon assessment

Time frame

Preoperative

Other outcomes

Type of axillary surgery

Type of axillary procedure performed at the time of breast surgery

Time frame

At surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Uppsala University Hospital

Collaborator

Royal Marsden NHS Foundation Trust

Collaborator

University of Sydney

Collaborator

Breast Unit, University Campus Biomedico, Rome, Italy

Collaborator

Source ClinicalTrials.gov

Apply now