Screening and Care for Fear of Cancer Recurrence in Patients With Cancer at Institut Curie
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Curie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Lung cancer
Group B: Breast cancer
Trial outcomes
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.
Time frame
Within 1 month after inclusionSecondary outcomes
1
Emergent themes related to perceptions of cancer, fear of recurrence, psychological responses, and satisfaction with support resources.
Semi-structured qualitative interviews with 40 stratified patients. Thematic analysis of cognitive, emotional, behavioural responses, and internal and external resources.
Time frame
Within 1 month after inclusionSponsors and contacts
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Source ClinicalTrials.gov