Breast CancerAELONCT07267572
Evaluation of the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer
A study testing Support to the patient including logotherapy and Support to the patient without logotherapy in people with Breast Cancer, run by Elsan at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Support to the patient including logotherapy and Support to the patient without logotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique du Fief de Grimoire
Poitiers, 86000
Emmanuelle MALHOMME, +33 5 49 42 29 29, Emmanuelle.MALHOMME@elsan.care
About this study
Official title: 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.
Read more
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
- Being tested
- Support to the patient including logotherapy, Support to the patient without logotherapy
- Keywords
- logotherapy, support, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support to the patient including logotherapyOther
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 logotherapyOther
Supportive care offered as part of the patient notification process following the diagnosis of breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Support within the framework of the "announcement procedure" with logotherapy | Experimental | Not described Receives: Other: Support to the patient including logotherapy |
| Support within the framework of the "announcement procedure" without logotherapy | Active comparator | Not described Receives: Other: Support to the patient without logotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 10 weeks
Secondary outcomes (6)
Anxiety and depression
HADS score (anxiety and depression).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Over 9 months
Anxyolitic treatments consumption
Number of anxyolitic treatments (type, dose and indication)
Measured: 10 weeks, 6 months and 9 months
Anti-depressant treatments consumption
Number of anti-depressant treatments (type, dose and indication)
Measured: 10 weeks, 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267572
- Sponsor's protocol ID
- AELO
- Other IDs
- 2024-A02252-45
- Acronym
- AELO
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative Study to Evaluate the Added Value of Logotherapy in the Psychological Support of Patients With Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT07267572
- Acronym / sponsor ID
- AELO / AELO
- Conditions
- Breast Cancer
- Keywords
- logotherapy, support, breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support to the patient including logotherapyLogotherapy 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. | Other | Support within the framework of the "announcement procedure" with logotherapy |
| Support to the patient without logotherapySupportive care offered as part of the patient notification process following the diagnosis of breast cancer. | Other | Support within the framework of the "announcement procedure" without logotherapy |
Primary outcome
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.
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).
6 secondary outcomes
Anxiety and depression
Time frame: Baseline, 10 weeks, 6 months and 9 months
Perceived stress
Time frame: Baseline, 10 weeks, 6 months and 9 months
Quality of life assessment
Time frame: Baseline, 10 weeks, 6 months and 9 months
Consultations of psychotherapists
Time frame: Over 9 months
Anxyolitic treatments consumption
Time frame: 10 weeks, 6 months and 9 months
Anti-depressant treatments consumption
Time frame: 10 weeks, 6 months and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support to the patient including logotherapy and Support to the patient without logotherapy in people with Breast Cancer, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle MALHOMME (+33 5 49 42 29 29, Emmanuelle.MALHOMME@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.