Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRamsay Générale de Santé

About this trial

The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled

Age> 18 years old

Performance status ECOG <2

Patient speaking and understanding French and able to complete questionnaires

Disqualifiers

male

Patient with metastatic breast cancer

Patient with bilateral breast cancer

History of cancer of less than 5 years

Trial population

Women patient with breast cancer

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Quality of life questionnaires

    Behavioral

    Different quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: Patient seeking supportive care1 intervention
Group B: Patient without any supportive care1 intervention

Trial outcomes

Primary outcomes

1

Quality of life questionnaire : FACT-B

Functional Assessment of Cancer Therapy-breast : 27 items about physical well-being, family well-being, emotional and functional well-being. The quotation is between 0 "not at all" and 4 "verry much". The total score is between 0 and 148. The higher the scores, the higher the QoL and the various well-being.

Time frame
12 months
2

Quality of life questionnaire : EORTC QLQ-C30

30 items for all patient suffering from cancer. The answer of each question is between 1 "not at all" and 4 "very much"

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Ramsay Générale de Santé

Lead sponsor

European Clinical Trial Experts Network

Collaborator