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

NCT06401304 | Recruiting

• 1 other identifier: UUBreast04
• Study Type: observational
• Target: 1,200
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Invasive; Breast Asymmetry

Keywords

Oncoplastic breast conservation; Breast Conserving Surgery; Patient reported outcomes; Shared decision making

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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

  Baseline, postoperative (6, 12, 24 months)

• Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest

  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 Physical Wellbeing: Chest module is summarized in a score ranging from 0 to 100, with higher scores denoting higher wellbeing

  Baseline, postoperative (6, 12, 24 months)

Secondary Outcomes (10)

• Postoperative Complications

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

• Operative time

  At surgery

• Length of stay

  Perioperative

• Profile of mastectomy candidates

  Preoperative

• Procedure-related costs

  Postoperative

Other Outcomes (1)

• Type of axillary surgery

  At surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

As discussed above

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• Westmead Breast Cancer Institute, Sydney University, Sydney, Australia: collaborator
• Breast Unit, University Campus Biomedico, Rome, Italy: collaborator

Study Sites (3)

Westmead Breast Cancer Institute

Sydney, Australia

RECRUITING

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Royal Marsden Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Anisomastia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Andreas Karakatsanis, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas U Karakatsanis, MD, PhD

CONTACT

+46765864826; andreas.karakatsanis@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 6, 2024
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 30, 2032
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

SE (1); GB (1); AU (1)