Evaluation of the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Support to the patient including logotherapy, Support to the patient without logotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized, Comparative Study to Evaluate the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer
Overview
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
- Other Support 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. - Other Support to the patient without logotherapy
Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.
Primary outcome measures
- Anxiety [Time frame: 10 weeks]
- Depression [Time frame: 10 weeks]
Secondary outcome measures (6)
- Anxiety and depression [Time frame: Baseline, 10 weeks, 6 months and 9 months]
- Perceived stress [Time frame: Baseline, 10 weeks, 6 months and 9 months]
- Quality of life assessment [Time frame: Baseline, 10 weeks, 6 months and 9 months]
- Consultations of psychotherapists [Time frame: Over 9 months]
- Anxyolitic treatments consumption [Time frame: 10 weeks, 6 months and 9 months]
- Anti-depressant treatments consumption [Time frame: 10 weeks, 6 months and 9 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Clinique du Fief de Grimoire — Poitiers
Identifiers
NCT: NCT07267572 · AELO · 2024-A02252-45