Breast CancerFASTRACS-RCTNCT04846972
Facilitate and Sustain Return to Work After Breast Cancer
An observational study of Breast Cancer, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FASTRACS intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 420 participants
- Where
- 11 sitesFrance
- Study dates
- 21 May 2021to Dec 2023
- Phase
- Observational
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 to 55 with first invasive non-metastatic breast cancer (treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation) and in paid employment at the time of diagnosis.
Who may be able to join
- Woman aged between 18 and 55
- With a diagnosis of invasive breast carcinoma of stage cTNM or pTNM I to III (UICC 8th edition), confirmed by histological examination
- Treated by intravenous cytotoxic chemotherapy in an adjuvant or neoadjuvant situation
- Breast surgery +/- of the axillary area, carried out within 3 months preceding the start of adjuvant chemotherapy, or scheduled after neo-adjuvant chemotherapy +/- radiotherapy.
- In salaried employment at the time of diagnosis (permanent or temporary contract, interim assignment, civil servant)
- Affiliated to a French social security scheme
Show all 9Show fewer
- Reading, understanding and writing the French language
- Followed in one of the investigating centers
- Not opposing the collection of data
Who cannot join
- In situ carcinoma
- Distant metastases
- History or co-existence of another primary cancer (apart from a basal cell cancer of the skin and / or a non-mammary cancer in complete remission for more than 5 years)
- Recurrence or second breast cancer
- Without employment contract; self-employed or supported contract
- Cannot be followed for the duration of the study, for medical, social, family, geographic or psychological reasons
- Deprived of liberty by court or administrative decision
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Hôpital Fleyriat
Bourg-en-Bresse, 01012
Hubert Orfeuvre, MD, +33 4 74 45 43 38, Hubert.horfeuvre@ch-bourg01.fr
Hubert ORFEUVRE, MD
- Recruiting
Hopital femme mère enfant, Hospices Civils de Lyon
Bron, 69500
Christophe SAJOUS, MD, 4 27 85 65 77 ext. +33, christophe.sajous@chu-lyon.fr
- Recruiting
Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND
Clermont-Ferrand
Xavier DURANDO, MD, +33 4 73 27 80 80, xavier.durando@clermont.unicancer.fr
- Recruiting
Hopital de la croix rousse, Hospices Civils de Lyon
Lyon, 69004
Amandine BRUYAS, MD, amandine.bruyas@chu-lyon.fr
- Recruiting
Centre Léon Berard
Lyon, 69008
Pierre HEUDEL, MD, pierre.heudel@lyon.unicancer.fr
- Recruiting
Hopital privé Jean Mermoz
Lyon, 69008
Olfa DERBEL, MD, derbelolfa@yahoo.fr
- Recruiting
Service d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, 74370
Laëtitia STEFANI, MD, +33 4 50 63 63 63, lstefani@ch-annecygenevois.fr
Laëtitia STEFANI, MD
- Recruiting
Hopital Lyon sud, Hospices civils de Lyon
Pierre-Bénite, 69495
Julien PERON, MD, 4 78 86 37 75 ext. +33, julien.peron@chu-lyon.fr
- Recruiting
Centre Hospitalo-universitaire de saint Etienne
Saint-Etienne
Narjes Djehal, MD, +33 4 77 91 70 25, Nardjes.Djehal@chu-st-etienne.fr
- Recruiting
Clinique Charcot
Sainte-Foy-lès-Lyon, 69110
Nicolas CARRABIN, MD, docteur.carrabin@gmail.com
- Recruiting
Centre Hospitalier de Valence
Valence, 26953
Dominique Dramais, MD, +33 4 75 75 75 75, ddramais@ch-valence.fr
Bruno ANGLARET, MD
About this study
Official title: Facilitate and Sustain Return to Work After Breast Cancer: Randomized Controlled Trial
Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol.
The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer.
Read more
Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category.
The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process.
The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools).
Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.
- Conditions
- Breast Cancer
- Being tested
- FASTRACS intervention
- Keywords
- Work rehabilitation, Social psychology, Work psychology, Occupational health and medicine, Health program planning, Breast cancer, Work disability prevention, Intervention mapping
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTRACS interventionBehavioural
Intervention (4 steps) :
- Penultimate to last chemotherapy : patient will receive tools of the intervention
- 1 month after the end of oncological treatment (OT): patient will attend a general medicine consultation with the GP RTW checklist
- 2 months after OT: patient will attend a pre RTW visit with the OP RTW checklist
- 5 months after the end of OT: if the patient has not returned to work 10 months after inclusion, they will have a visit with an OP-RTW to work coordinator
Self-questionnaires will evaluate quality of life (EORTC QLQC30, BR23, Euroqol (EQ-5D-5L)), anxiety and depression (HAD), employment status, self-efficacy to return to work (RTW-SE11), pre-RTW and RTW visit with the OP, social support, care consumption, physical activity (short IPAQ), perceived performance (WRF), work conditions. The implementation and use of the intervention tools will also be assessed: the patient guide, the employer guide, RTW checklists for the GP and the OP.
| Study group | Role | What they receive |
|---|---|---|
| Control group | After inclusion, patients will receive standard care. Women allocated in this group will have the standard care. | |
| FASTRACS intervention group | Women allocated in the FASTRACS intervention group will follow a structured care pathway comprising three successive steps (end of chemotherapy interview with a nurse, transitional visit with their GP, pre-RTW visit with their OP), plus one optional step (late visit with an OP- RTW to work coordinator). Four tools will be used during the intervention (RTW guide or checklist for the patient, the GP, the OP and the employer). Receives: Behavioral: FASTRACS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
(a) a sustained return to work between inclusion and 12 months after oncological treatments; and (b) the number of days on sick leave between inclusion and 12 months after oncological treatments .
The main analysis of the primary endpoint will be based on the net benefit of the intervention, estimated using the generalized pairwise comparison method
Measured: 12 months after oncological treatments (radiation therapy, or chemotherapy for patients without radiation therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start21 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846972
- Sponsor's protocol ID
- 69HCL16_0536
- Acronym
- FASTRACS-RCT
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fassier JB, Guittard L, Fervers B, Rouat S, Sarnin P, Carretier J, Broc G, Letrilliart L, Peron J, Lamort-Bouche M. Using intervention mapping to facilitate and sustain return-to work after breast cancer: protocol for the FASTRACS multicentre randomized controlled trial. BMC Cancer. 2024 Sep 5;24(1):1107. doi: 10.1186/s12885-024-12796-4.
PubMed 39237867
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitate and Sustain Return to Work After Breast Cancer: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04846972
- Acronym / sponsor ID
- FASTRACS-RCT / 69HCL16_0536
- Conditions
- Breast Cancer
- Keywords
- Work rehabilitation, Social psychology, Work psychology, Occupational health and medicine, Health program planning, Breast cancer, Work disability prevention, Intervention mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Apr 2021 (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.
Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol.
The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer.
Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category.
The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process.
The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools).
Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –After inclusion, patients will receive standard care. Women allocated in this group will have the standard care. |
| FASTRACS intervention group | – | Behavioral: FASTRACS interventionWomen allocated in the FASTRACS intervention group will follow a structured care pathway comprising three successive steps (end of chemotherapy interview with a nurse, transitional visit with their GP, pre-RTW visit with their OP), plus one optional step (late visit with an OP- RTW to work coordinator). Four tools will be used during the intervention (RTW guide or checklist for the patient, the GP, the OP and the employer). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 55 with first invasive non-metastatic breast cancer (treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation) and in paid employment at the time of diagnosis.
Key inclusion criteria (9 listed)
- Woman aged between 18 and 55
- With a diagnosis of invasive breast carcinoma of stage cTNM or pTNM I to III (UICC 8th edition), confirmed by histological examination
- Treated by intravenous cytotoxic chemotherapy in an adjuvant or neoadjuvant situation
- Breast surgery +/- of the axillary area, carried out within 3 months preceding the start of adjuvant chemotherapy, or scheduled after neo-adjuvant chemotherapy +/- radiotherapy.
- In salaried employment at the time of diagnosis (permanent or temporary contract, interim assignment, civil servant)
Key exclusion criteria (7 listed)
- In situ carcinoma
- Distant metastases
- History or co-existence of another primary cancer (apart from a basal cell cancer of the skin and / or a non-mammary cancer in complete remission for more than 5 years)
- Recurrence or second breast cancer
- Without employment contract; self-employed or supported contract
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 |
|---|---|---|
| FASTRACS interventionIntervention (4 steps) : * Penultimate to last chemotherapy : patient will receive tools of the intervention * 1 month after the end of oncological treatment (OT): patient will attend a general medicine consultation with the GP RTW checklist * 2 months after OT: patient will attend a pre RTW visit with the OP RTW checklist * 5 months after the end of OT: if the patient has not returned to work 10 months after inclusion, they will have a visit with an OP-RTW to work coordinator Self-questionnaires will evaluate quality of life (EORTC QLQC30, BR23, Euroqol (EQ-5D-5L)), anxiety and depression (HAD), employment status, self-efficacy to return to work (RTW-SE11), pre-RTW and RTW visit with the OP, social support, care consumption, physical activity (short IPAQ), perceived performance (WRF), work conditions. The implementation and use of the intervention tools will also be assessed: the patient guide, the employer guide, RTW checklists for the GP and the OP. | Behavioural | FASTRACS intervention group |
Primary outcome
(a) a sustained return to work between inclusion and 12 months after oncological treatments; and (b) the number of days on sick leave between inclusion and 12 months after oncological treatments .
Time frame: 12 months after oncological treatments (radiation therapy, or chemotherapy for patients without radiation therapy)
The main analysis of the primary endpoint will be based on the net benefit of the intervention, estimated using the generalized pairwise comparison method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 39237867Fassier JB, Guittard L, Fervers B, Rouat S, Sarnin P, Carretier J, Broc G, Letrilliart L, Peron J, Lamort-Bouche M. Using intervention mapping to facilitate and sustain return-to work after breast cancer: protocol for the FASTRACS multicentre randomized controlled trial. BMC Cancer. 2024 Sep 5;24(1):1107. doi: 10.1186/s12885-024-12796-4.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hospices Civils de Lyon at 11 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 9 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste FASSIER, MD (4 78 86 18 94 ext. +33, jean-baptiste.fassier@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(a) a sustained return to work between inclusion and 12 months after oncological treatments; and (b) the number of days on sick leave between inclusion and 12 months after oncological treatments . (time frame: 12 months after oncological treatments (radiation therapy, or chemotherapy for patients without radiation therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846972, which also lists 1 linked publication.
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 27 Feb 2023.