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NCT Number: NCT07267572

Evaluation of 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 to the patient without logotherapy

Other

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

Primary outcomes

  1. Anxiety

    Time frame: 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.

  2. Depression

    Time frame: 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 outcomes

  1. Anxiety and depression

    Time frame: Baseline, 10 weeks, 6 months and 9 months

    HADS score (anxiety and depression).

  2. Perceived stress

    Time frame: 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)

  3. Quality of life assessment

    Time frame: 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.

  4. Consultations of psychotherapists

    Time frame: Over 9 months

    Number of consultations with a specialist in psychotherapy in relation to breast cancer management.

  5. Anxyolitic treatments consumption

    Time frame: 10 weeks, 6 months and 9 months

    Number of anxyolitic treatments (type, dose and indication)

  6. Anti-depressant treatments consumption

    Time frame: 10 weeks, 6 months and 9 months

    Number of anti-depressant treatments (type, dose and indication)

Study contacts

Contact information is provided by the study sponsor or research team.

Charlène PY

CONTACT

[email protected]

+33 5 56 00 30 48

Emmanuelle MALHOMME

CONTACT

[email protected]

+33 5 49 42 29 29

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: AELO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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