Realistic Evaluation of a Job Retention Program After Breast Cancer

Breast Cancer Clinical Trial

— RECOVA-FTRACS  

Official title:

Realistic Evaluation of a Job Retention Program After Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919498
• Other study ID #: 22-5143
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: Marion LAMORT BOUCHE, MD
• Phone: 04 72 11 28 04
• Email: marion.lamort-bouche[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Returning to and maintaining employment after cancer is essential for restoring social participation, financial independence and reducing the social costs associated with cancer. Many obstacles that prevent or delay the return to work have been identified. They are associated with the consequences of the disease and treatments such as fatigue, pain and cognitive disorders, the lack of collaboration between health professionals (oncologists, general practitioners and occupational physicians), and the characteristics of the environment. in terms of the demands of the job, and the (lack of) social support from superiors and colleagues. There are social inequalities in the return to work after cancer, with a poorer professional prognosis among older and less qualified people. Social inequalities linked to ethnicity have been documented in other countries. In France, 58,500 new cases of breast cancer are diagnosed each year, half of them in women of working age. The importance of job retention has been formalized in the objectives of the latest cancer plans, and in the 2018-2022 national health strategy. Initiatives are observed to promote this issue by employers: development of a charter by the National Cancer Institute and in the associative field aimed at promoting support practices in their professional environment for people with cancer. Despite the development of descriptive knowledge on prognostic factors for returning to work after cancer, the results of interventional studies are mixed. No intervention has been shown to be effective in facilitating return to work and reducing social disparities in employment after breast cancer. Interventions have been criticized for being too medicalized and lacking a sufficient theoretical basis to analyse causes (theory of the problem) and propose solutions (theory of action). The "FASTRACS" intervention was developed with the Intervention Mapping protocol to facilitate the return to work after breast cancer, it defines a return-to-work path from the hospital to the company through care primaries. This intervention is anchored in primary care with an early transition consultation in general medicine in the month following the end of active treatments (chemotherapy or radiotherapy according to the care protocol). This positioning in primary care allows a bio-psycho-social assessment of the needs of women after cancer. This consultation was designed to establish a plan of care and return to work according to the temporality and individual needs of each woman. It will make it possible to determine the right time for the pre-recovery visit in order to anticipate the professional challenges of the recovery. Return to work/maintenance in employment interventions are complex social interventions, implemented by social actors who act in an environment with which they interact. These interventions (or programs) present an increased risk of failure in their implementation and sustainability. Realistic evaluation comes from the trend of theory-based evaluation (theory-based or theory-driven evaluation). According to this approach, social interventions are based on theories, which can be tested through empirical observation to better understand how and why they produce their effects, and in what context. This approach overcomes the limits of the "black box" model. It is recommended to inform the public decision to interrupt, modify or intensify an intervention. It aims to answer the question: "what works, how, why, for whom, and under what circumstances?" ". It aims to describe the mechanisms of the effectiveness of an intervention by linking its effects to the characteristics of its implementation context (search for CME configurations = context - mechanisms - effects). The search for these configurations, otherwise called "half-regularities" because they can be observed empirically with certain variations, is intended to develop a middle-range theory with a sufficient level of generalization and abstraction. to explain the tendencies and the regularities observed in the interactions contexts-mechanisms-effects of the intervention. This approach is particularly indicated in the evaluation of the FASTRACS intervention, given the complexity of the intervention, the number of actors involved, and the variety of its implementation contexts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria concerning FASTRACS-RCT participants (groupe 1) * :
• Patients included in the intervention arm of the "FASTRACS-RCT" trial who have completed their participation in the trial.
• Woman aged between 18 and 55.
• With a diagnosis of invasive breast carcinoma of stage cTNM or pTNM stage I to III (UICC 8th edition), confirmed on 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 neoadjuvant 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.
• Reading, understanding, and writing the French language.
• Followed in one of the investigating centers.
• Not opposing the collection data.
• Inclusion Criteria * :
• Persons declared by the patients for the study of the trajectories and only if their agreement is obtained for each person concerned (general practitioner, occupational physician, personnel of the resource center fort occupational and environmental pathologies (CRPPE), colleagues and hierarchy in the company and any key person identified by the patient who participated in the recovery process using the intervention tools).(groupe 2)
• Participants in discussion groups independent of trajectories (oncologists, clinical research associates, general practitioners, occupational health teams and CRPPE staff). (Groupe 3)
• For all categories of participants, it is necessary to be of legal age, to be able to read, understand and speak French.
• Exclusion Criteria concerning FASTRACS-RCT participants (groupe 1)* :
• In situ carcinoma.
• Distant metastases.
• History or co-existence of another primary cancer (apart from a basal cell cancer of the skin and/or 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, geographical or psychological reasons.
• Deprived of liberty by court or administrative decision.
• Exclusion Criteria * :
• No exclusion criteria concern participants related to patients (declared by patients) (groupe 2).
• No exclusion criteria for the people delivering the intervention (focus group participants) (groupe 3).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Individual semi-directive interview
This intervention concerns the trajectories of patients who have completed their participation in FASTRACS-RCT. Participant are : patients in the FASTRACS-RCT intervention arm (Groupe 1) and Trajectory persons (groupe 2). During the individual interviews, the investigator and the participant will discuss the use of the FASTRACS-RCT tools and the patient's course of care. The individual interviews will take place at the location chosen by the participant and will last on average one hour.
• Focus groups
This second intervention will take place at the end of the last patient followed by the FASTRACS-RCT. During the focus groups, participants will discuss the use of the FASTRACS-RCT tools. The focus groups will take place in a meeting room made available for the occasion and will last on average two hours.

Locations

Country	Name	City	State
France	Pôle de Santé Publique des Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual semi-directive interviews on barriers and facilitators to the implementation of FASTRACS-RCT intervention	To identify barriers and facilitators to the implementation of FASTRACS-RCT intervention, we will measure the return-to-work mechanism of women who have had breast cancer, using a 29-question semi-structured interview.	Individual interviews will be conducted from the end of their follow-up in FASTRACS-RCT, and during the following 18 months.