Breast CancerAPAPINCT01780064
Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer
A study testing interviews with a psychologist and Questionnaires in people with Breast Cancer, run by Centre Oscar Lambret at 7 sites in France.
Trial summary
The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- interviews with a psychologist and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 7 sitesFrance
- Study dates
- Feb 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 with work at the time of diagnosis
- Presenting a unilateral breast cancer exclusively local extension
- Having received surgery
- Reporting of adjuvant chemotherapy (+ / - trastuzumab)
- Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
- In work at the time of diagnosis (employees, traders and professionals)
- Patient affiliated to a social security scheme
- Consent signed by the patient before the implementation of any specific procedure to study
Who cannot join
- Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
- Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
- Recognition previous ALD (due to another disease)
- Patient under guardianship
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Marie Curie
Arras, 62000
Centre Pierre Curie
Beuvry, 62880
Centre Léonard de Vinci
Dechy, 59187
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier
Valenciennes, 59300
Nouvelle Clinique des Dentellières
Valenciennes, 59300
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59657
About this study
Official title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer
The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
Read the detailed description
For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).
In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)
- Conditions
- Breast Cancer
- Being tested
- interviews with a psychologist, Questionnaires
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviews with a psychologistBehavioural
interviews with a psychologist
QuestionnairesBehavioural
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Placebo comparator | routine monitoring with questionnaires Receives: Behavioral: Questionnaires |
| Interviews with psychologist | Active comparator | Patients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires Receives: Behavioral: interviews with a psychologist; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
Measured: At 24 months
Secondary outcomes (2)
Comparison between the two modes of care, of social inequalities:
- On the quality of the return to employment (working conditions, job stability)
- On individual and collective resources of patients (social encouragement received, reactions to issues, anxiety/depression, quality of life, etc)
Measured: At 24 months
Calculating the cost / benefit ratio of the two modes of care
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionJan 2018
Why it stopped: Lack of enrollment
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Sophie FANTONI, MD, PhD, Study director, CHRU / Université Lille 2Jacques BONNETERRE, MD, PhD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780064
- Sponsor's protocol ID
- APAPI-1202
- Other IDs
- 2012-A00315-38
- Acronym
- APAPI
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2013
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01780064
- Acronym / sponsor ID
- APAPI / APAPI-1202
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Jan 2013 (estimated)
- 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 purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
Detailed description
For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).
In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Placebo comparator | Behavioral: Questionnairesroutine monitoring with questionnaires |
| Interviews with psychologist | Active comparator | Behavioral: interviews with a psychologist, Behavioral: QuestionnairesPatients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women ≥ 18 with work at the time of diagnosis
- Presenting a unilateral breast cancer exclusively local extension
- Having received surgery
- Reporting of adjuvant chemotherapy (+ / - trastuzumab)
- Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
Key exclusion criteria (4 listed)
- Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
- Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
- Recognition previous ALD (due to another disease)
- Patient under guardianship
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 |
|---|---|---|
| interviews with a psychologistinterviews with a psychologist | Behavioural | Interviews with psychologist |
| QuestionnairesQuestionnaires | Behavioural | Interviews with psychologist, Standard group |
Primary outcome
Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
Time frame: At 24 months
2 secondary outcomes
Comparison between the two modes of care, of social inequalities:
Time frame: At 24 months
Calculating the cost / benefit ratio of the two modes of care
Time frame: At 24 months
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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. This study is not recruiting at the moment.
Sophie FANTONI, MD, PhD study director
CHRU / Université Lille 2
Jacques BONNETERRE, MD, PhD study director
Centre Oscar Lambret
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interviews with a psychologist and Questionnaires in people with Breast Cancer, run by Centre Oscar Lambret at 7 sites 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work (time frame: At 24 months). 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 18 Mar 2026.