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

Randomized, Comparative Study to Evaluate the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Support to the patient including logotherapy; Other: Support to the patient without logotherapy

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuelle MALHOMME; Phone Number: +33 5 49 42 29 29; Email: Emmanuelle.MALHOMME@elsan.care
• Study Contact Backup: Name: Charlène PY; Phone Number: +33 5 56 00 30 48; Email: charlene.py@elsan.care

Study Locations

• France
  • Poitiers, France, 86000
    • Clinique du Fief de Grimoire
    • Contact: Emmanuelle MALHOMME; Phone Number: +33 5 49 42 29 29; Email: Emmanuelle.MALHOMME@elsan.care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Support within the framework of the "announcement procedure" with logotherapy	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.
Active Comparator: Support within the framework of the "announcement procedure" without logotherapy	Other: Support to the patient without logotherapy; Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	10 weeks
Depression	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).	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression	HADS score (anxiety and depression).	Baseline, 10 weeks, 6 months and 9 months
Perceived stress	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)	Baseline, 10 weeks, 6 months and 9 months
Quality of life assessment	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.	Baseline, 10 weeks, 6 months and 9 months
Consultations of psychotherapists	Number of consultations with a specialist in psychotherapy in relation to breast cancer management.	Over 9 months
Anxyolitic treatments consumption	Number of anxyolitic treatments (type, dose and indication)	10 weeks, 6 months and 9 months
Anti-depressant treatments consumption	Number of anti-depressant treatments (type, dose and indication)	10 weeks, 6 months and 9 months

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; support; logotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Logotherapy
• Other Study ID Numbers: AELO; 2024-A02252-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No