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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in France

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 groups in NCT04846972
Study groupRoleWhat they receive
Control groupAfter inclusion, patients will receive standard care. Women allocated in this group will have the standard care.
FASTRACS intervention groupWomen 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.

  1. (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.

  1. First posted15 Apr 2021
  2. Study start21 May 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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)
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

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.

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