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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorElsan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Support to the patient including logotherapy

    Other intervention

    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 intervention

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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Support within the framework of the "announcement procedure" with logotherapyExperimental treatment 1 intervention
Group B: Support within the framework of the "announcement procedure" without logotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
10 weeks
2

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).

Time frame
10 weeks

Secondary outcomes

1

Anxiety and depression

HADS score (anxiety and depression).

Time frame
Baseline, 10 weeks, 6 months and 9 months
2

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)

Time frame
Baseline, 10 weeks, 6 months and 9 months
3

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.

Time frame
Baseline, 10 weeks, 6 months and 9 months
4

Consultations of psychotherapists

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

Time frame
Over 9 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: