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NCT Number: NCT06761196

Quality of Life After Breast Cancer Surgery

The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.

Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.

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Key information

Conditions

Breast Cancer Surgery Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location status: Recruiting

Location contact

Delphine Weitbruch

SUB_INVESTIGATOR

Massimo Lodi

PRINCIPAL_INVESTIGATOR

Massimo Lodi, MD

CONTACT

[email protected]

0033389124171

Sylvia Mazellier

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 or over
  • Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
  • Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
  • Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
  • Patient with a computer, tablet or smartphone connected to the Internet.
  • Patient followed in the center on a regular basis according to standard recommendations.

Exclusion criteria

  • Patient requiring surgical intervention under local anesthesia only.
  • Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
  • Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
  • Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
  • Patient under protective measure

Treatment and study plan

Questionnaire

Other

The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42)

Primary outcomes

  1. Quality of life measured with BREAST-Q

    Time frame: From enrollment to the end of 5 years follow-up

    The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. There is three independent modules developped for breast cancer (mastectomy, breast-conserving therapy, reconstruction).

    A conversion table is used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

Secondary outcomes

  1. Quality of life measured with EORTC QLQ C30

    Time frame: From enrollment to the end of 5 years follow-up

    The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

    Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  2. Quality of life measured with EORTC QLQ-BR42

    Time frame: From enrollment to the end of 5 years follow-up

    The Breast Cancer Module EORTC QLQ-BR42 is a 42-item instrument designed to measure quality of life in breast cancer patients. It is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. All of the scales and single item measures range in score from 0 to 100. A high score for the Body Image, Sexual Functioning and Breast Satisfaction scales and for the Future Perspective and Sexual Enjoyment single items represents a high level of functioning, whereas a high score for the Systemic ChemoTherapy Side Effects, Endocrine Symptoms, Arm Symptoms, Breast Symptoms, Hand/foot symptoms/neuropathy, Skeletal Scale and Vaginal Symptoms scales and for the Weight Gain single item represents a high level of symptomatology or problems.

  3. Safety of postoperative period

    Time frame: Form enrollment to the end of 5 years follow-up

    Concerning safety, the endpoint is the duration of Hospital Free Survival (HFS) . HFS is defined as the time interval (in days) without any hospitalization from discharge until death.

  4. Quality of postoperative period

    Time frame: At enrollment aund day 1 and 7 after surgery

    Concerning the quality of the postoperative period, the enpoint is the quality of recovery assessed with the 15-item Quality of Recovery (QoR-15) scale.

    The QoR-15 scale is a validated multidimensional questionnaire that measures postoperative quality of recovery. The scale is ranges from 0 to 150. A higher QoR-15 score reflects higher recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Magali EYRIEY

CONTACT

[email protected]

0033389124810

Massimo LODI, MD

CONTACT

[email protected]

0033389124171

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Colmar

Other

Registry information

Official study title

Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study

Acronym: SOCOM-QoL

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Jan 7, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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