Screening and Care for Fear of Cancer Recurrence in Patients With Cancer at Institut Curie

NCT07357311 | Recruiting

• 1 other identifier: IC 2025-08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study is to establish the prevalence of severe forms of FCR in the oncology hospital setting, which will require a specific psychotherapeutic response. Two cancer sites are targeted: breast and pulmonary cancers. Secondary objectives include: 1) Determining threshold scores for the FCRI's 9-item severity scale for each type of cancer; 3) To identify a simple item from the FCRI for early detection of FCR in everyday clinical practice, especially using a digital format.

Conditions

Lung Cancer; Breast Cancer

Keywords

FCR; FoP; Lung cancer; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients scoring above a cut-off on the 9-item Fear of cancer recurrence inventory (FRCI) severity scale

  The proportion of patients scoring above a cut-off on the 9-item FRCI severity scale of the 'Fear of cancer recurrence inventory the (FCRI) (Simard \& Savard, 2009), reflecting severe FCR and the need for specialised psycho-oncological care.

  Within 1 month after inclusion

Secondary Outcomes (1)

• Emergent themes related to perceptions of cancer, fear of recurrence, psychological responses, and satisfaction with support resources.

  Within 1 month after inclusion

Study Arms (2)

Lung cancer

Breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer or breast cancer at all stages of the disease, three months after treatment completion or three months after the start of a first treatment line for a metastatic progression.

You may qualify if:

• Aged 18 or over
• Clinical or pathological diagnosis of primary or recurrence of a localized/loco-regional or metastatic breast cancer, or a stage 1 or 2, or stage 3 or 4 lung cancer; or a breast or lung cancer metastatic progression
• Three months after completing treatment or three months after the start of a first treatment line for metastatic progression
• Able to comply with the scheduled assessment and interviews
• Able to read and understand the questionnaires' language (i.e. French)

You may not qualify if:

• Participating in another patient-reported outcome study interfering with the present study
• Any social, medical or psychological condition hindering questionnaire completion
• Being deprived of personal liberty or under guardianship

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anne Bredart, Ph.D

CONTACT

+33 1 44 32 43 50; anne.bredart@curie.fr

Carole Cagnot

CONTACT

carole.cagnot@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start: September 8, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)