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

E

Elsan

Status

Not yet enrolling

Conditions

Breast Cancer

Treatments

Other: Support to the patient including logotherapy
Other: Support to the patient without logotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07267572
AELO
2024-A02252-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

66 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Support within the framework of the "announcement procedure" with logotherapy
Experimental group
Treatment:
Other: Support to the patient including logotherapy
Support within the framework of the "announcement procedure" without logotherapy
Active Comparator group
Treatment:
Other: Support to the patient without logotherapy

Trial contacts and locations

1

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Central trial contact

Charlène PY; Emmanuelle MALHOMME

Data sourced from clinicaltrials.gov

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