Evaluation of the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer

NCT ID: NCT07267572

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-11-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Support within the framework of the "announcement procedure" with logotherapy

Group Type: EXPERIMENTAL

Support to the patient including logotherapy

Intervention Type: OTHER

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.

Support within the framework of the "announcement procedure" without logotherapy

Group Type: ACTIVE_COMPARATOR

Support to the patient without logotherapy

Intervention Type: OTHER

Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.

Interventions

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.

Intervention Type: OTHER

Support to the patient without logotherapy

Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique du Fief de Grimoire

Poitiers, , France

Countries

France

Central Contacts

Emmanuelle MALHOMME

Role: CONTACT

Emmanuelle.MALHOMME@elsan.care

+33 5 49 42 29 29

Charlène PY

Role: CONTACT

charlene.py@elsan.care

+33 5 56 00 30 48

Facility Contacts

Emmanuelle MALHOMME

Role: primary

Emmanuelle.MALHOMME@elsan.care

+33 5 49 42 29 29

Other Identifiers

2024-A02252-45

Identifier Type: OTHER

Identifier Source: secondary_id

AELO

Identifier Type: -

Identifier Source: org_study_id