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

NCT07267572 | Not Yet Recruiting

• 2 other identifiers: AELO2024-A02252-45
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

logotherapy; support; breast cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Anxiety and depression

  Baseline, 10 weeks, 6 months and 9 months

• Perceived stress

  Baseline, 10 weeks, 6 months and 9 months

• Quality of life assessment

  Baseline, 10 weeks, 6 months and 9 months

• Consultations of psychotherapists

  Over 9 months

• Anxyolitic treatments consumption

  10 weeks, 6 months and 9 months

Study Arms (2)

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

EXPERIMENTAL

Other: Support to the patient including logotherapy

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

ACTIVE COMPARATOR

Other: Support to the patient without logotherapy

Interventions

Support to the patient including logotherapy 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" with logotherapy

Support to the patient without logotherapy OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique du Fief de Grimoire

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Logotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Emmanuelle MALHOMME

CONTACT

+33 5 49 42 29 29; Emmanuelle.MALHOMME@elsan.care

Charlène PY

CONTACT

+33 5 56 00 30 48; charlene.py@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)