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Clinical Trials in Sweden / NCT06401304
Recruiting Observational

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

NCT06401304 · tracked via the Priya Life Science Sweden tracker
Sponsor
Uppsala University
Phase
Observational
Started
2020-01-01
Last updated
2024-05-06

Condition(s) studied

Breast CancerBreast Carcinoma in SituBreast Cancer InvasiveBreast Asymmetry

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Female aged above 18 years. 2. 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. 3. 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. 4. ECOG performance status 0-2. Exclusion Criteria 1. Life expectancy of less than 6 months 2. Non candidate for breast conservation 3. Inability to understand given information and give informed consent or undergo study procedures

Primary outcome measure(s)

  • Avoidance of mastectomy — 3 months
    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.
  • Re-excision rates — 3 months
    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.
  • Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) — Baseline, postoperative (6, 12, 24 months)
    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
  • Patient reported outcomes, BreastQ module for Satisfaction with Breasts — Baseline, postoperative (6, 12, 24 months)
    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
  • Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest — Baseline, postoperative (6, 12, 24 months)
    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

Trial sites (3)

FacilityCityRegionStatus
Westmead Breast Cancer Institute Sydney Australia Recruiting
Uppsala University Hospital Uppsala Sweden Recruiting
Royal Marsden Hospital London United Kingdom Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06401304 on ClinicalTrials.gov ↗ ← All trials in Sweden