Breast Cancer
Conditions
Keywords
logotherapy, support, breast cancer
Brief summary
The diagnosis of breast cancer in a woman can cause major psychological trauma with many destructive effects in all areas of life. Dealing with this profound distress is often difficult, sometimes poorly defined between different professionals (psychiatrists, psychologists, psychotherapists, proponents of alternative therapies), leading to highly variable and difficult-to-measure results. Since the first French cancer plan (2003/2007), facilities offering cancer care have been legally required to have a notification and support system in place. This consists of offering patients a range of supportive care throughout their cancer treatment (psychotherapy, physical activities, dietetics, pain management, etc.). In recent years, logotherapy has been offered as part of psychological care. Logotherapy is a form of psychotherapy based on meaning, which has been offered for many years and aims to help patients create or discover meaning in their lives. Meaning serves as motivation to continue living despite illness by placing this ordeal in the context of existence. Suffering can thus be transformed into opportunity. The use of logotherapy gives the suffering person the ability to take an active part in their treatment and helps them to mobilize their personal resources to keep the disease at bay, stabilize it, or cure it. Several studies conducted on women with breast or gynecological cancer have shown that logotherapy can reduce the symptoms of traumatic stress and increase their ability to find meaning in their lives. However, these studies have certain limitations because they are not randomized. In order to evaluate the short- and medium-term benefits of logotherapy in patients diagnosed with primary breast cancer, we propose a prospective, comparative, randomized study.
Interventions
OTHERSupport to the patient including logotherapy
Logotherapy consists of four individual sessions conducted by a nurse who is specialized and certified in logotherapy, at a rate of one session every two weeks, lasting approximately 60 minutes.
OTHERSupport to the patient without logotherapy
Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Female patient: * With a first diagnosis of histologically proven breast cancer, * Affiliated to a health insurance scheme, * Having been informed and having given her free and informed consent prior to any procedure specific to the study.
Exclusion criteria
Female patient: * Unable to understand the study and to answer to the questionnaires * With an indication for neoadjuvant chemotherapy * Undergoing antidepressant treatment at the time of diagnosis * Presenting with alcohol or drug addiction at the time of diagnosis * Protected: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision. * Pregnant, breastfeeding, or in labor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 10 weeks | Anxiety score of the Hospital Anxiety and Depression Scale (HADS) score. The HADS is a validated self-administered questionnaire consisting of 14 items allowing patients to assess their mood over the past week. It is composed of two parts (anxiety and depression) The result ranges from 0 to 21. |
| Depression | 10 weeks | Depression score of the HADS. This score will be analysed on a second step (two-step hierarchical sequential analysis) only if a significative difference is observable on the first step (anxiety). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress | Baseline, 10 weeks, 6 months and 9 months | Perceived Stress Scale (PSS) score. It is a validated self-administered questionnaire, comprising 10 questions assessing a patient's individual stress level. The result is expressed in a score between 0 (no perceived stress) and 40 (high perceived stress) |
| Anxiety and depression | Baseline, 10 weeks, 6 months and 9 months | HADS score (anxiety and depression). |
| Quality of life assessment | Baseline, 10 weeks, 6 months and 9 months | EORTC QJQ-C30. It is a general self-administered questionnaire comprising 30 questions to assess the quality of life of cancer patients participating in clinical trials. The result is expressed in a score between 0 and 100. |
| Consultations of psychotherapists | Over 9 months | Number of consultations with a specialist in psychotherapy in relation to breast cancer management. |
| Anxyolitic treatments consumption | 10 weeks, 6 months and 9 months | Number of anxyolitic treatments (type, dose and indication) |
| Anti-depressant treatments consumption | 10 weeks, 6 months and 9 months | Number of anti-depressant treatments (type, dose and indication) |
Countries
France
Contacts
Primary ContactEmmanuelle MALHOMME
Backup ContactCharlène PY
Outcome results
None listed