Lung CancerPDR-CARENCT07357311
Screening and Care for Fear of Cancer Recurrence in Patients With Cancer at Institut Curie
An observational study of Lung Cancer and Breast Cancer, run by Institut Curie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carole Cagnot contact
France1 site, 1 recruiting
- Recruiting
Institut Curie
Paris, 75005
Anne Bredart, Ph.D
About this study
Official title: Fear of Cancer Recurrence: Prevalence, Lived Experience and Satisfaction of Supportive Care Needs in the Hospital Care Pathway. A Mixed Method Study.
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.
Read the detailed description
Context and scientific background Fear of cancer recurrence (FCR) is a common concern among cancer patients. It has a significant impact on patients' quality of life and can lead to inappropriate health behaviours, which can hinder treatment management and patient survival. A Delphi survey identified the steps needed to pursue research in the field of FCR, in particular understanding its manifestations in specific populations. It also involves perfecting and culturally validating screening tools for FCR to ensure accurate detection and equitable access to appropriate care when needed. The Fear of Recurrence Inventory (FCRI) is, to date, the most widely validated tool for measuring FCR. However, its clinical use is limited due to its length and the absence of established cut-off scores, particularly for French-speaking populations.
Progresses in oncology mean that patients with advanced cancer can live longer. They differ from patients in remission and from terminally ill patients with an estimated life expectancy of less than a year. Therefore, their fears do not concern recurrence, but rather the progression of the disease. Their psychological state also differs from the concerns of end-of-life patients. Fear of progression is included in the definition of FCR (i.e. 'fear of worry that the cancer will return or progress. Yet fear of recurrence is seldom studied in patients with metastatic cancer. The aim is therefore to explore the specific features of the metastatic stage of the disease compared with the non-metastatic stage.
Methodology / Questionnaires / Hypothesis This is a mixed-method study. 200 patients will be identified consecutively, three months after a breast or lung cancer treatment completion or three months after the start of a first line of treatment for a metastatic progression. Both these cancer types have been selected in order to ensure recruitment feasibility in this study, as they are the most frequently treated at the Institut Curie. Study will include 100 patients per cancer type. Semi-structured clinical interviews will be conducted with these patients after they have completed the FCRI. These interviews' analyses will enable us to classify patients according to their FCR levels. Based on this classification, threshold scores for high FCR will be assessed for their sensitivity and specificity for both the 9-item scale and a single item. More in-depths qualitative interviews will be carried out with a random sample of 40 of these patients, stratified by cancer type and stage, in order to explore their perceptions of the disease, the risk of recurrence, their cognitive, emotional and behavioural responses to this risk, and their internal and external psychological resources. Satisfaction will also be assessed with the psychological resources currently available to cope with FCR.
- Conditions
- Lung Cancer, Breast Cancer
- Keywords
- FCR, FoP, Lung cancer, Breast cancer
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Not described | |
| Breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Semi-structured qualitative interviews with 40 stratified patients. Thematic analysis of cognitive, emotional, behavioural responses, and internal and external resources.
Measured: Within 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start8 Sep 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357311
- Sponsor's protocol ID
- IC 2025-08
- Acronym
- PDR-CARE
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Cancer Recurrence: Prevalence, Lived Experience and Satisfaction of Supportive Care Needs in the Hospital Care Pathway. A Mixed Method Study.
- ClinicalTrials.gov ID
- NCT07357311
- Acronym / sponsor ID
- PDR-CARE / IC 2025-08
- Conditions
- Lung Cancer, Breast Cancer
- Keywords
- FCR, FoP, Lung cancer, Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (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.
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.
Detailed description
Context and scientific background Fear of cancer recurrence (FCR) is a common concern among cancer patients. It has a significant impact on patients' quality of life and can lead to inappropriate health behaviours, which can hinder treatment management and patient survival. A Delphi survey identified the steps needed to pursue research in the field of FCR, in particular understanding its manifestations in specific populations. It also involves perfecting and culturally validating screening tools for FCR to ensure accurate detection and equitable access to appropriate care when needed. The Fear of Recurrence Inventory (FCRI) is, to date, the most widely validated tool for measuring FCR. However, its clinical use is limited due to its length and the absence of established cut-off scores, particularly for French-speaking populations.
Progresses in oncology mean that patients with advanced cancer can live longer. They differ from patients in remission and from terminally ill patients with an estimated life expectancy of less than a year. Therefore, their fears do not concern recurrence, but rather the progression of the disease. Their psychological state also differs from the concerns of end-of-life patients. Fear of progression is included in the definition of FCR (i.e. 'fear of worry that the cancer will return or progress. Yet fear of recurrence is seldom studied in patients with metastatic cancer. The aim is therefore to explore the specific features of the metastatic stage of the disease compared with the non-metastatic stage.
Methodology / Questionnaires / Hypothesis This is a mixed-method study. 200 patients will be identified consecutively, three months after a breast or lung cancer treatment completion or three months after the start of a first line of treatment for a metastatic progression. Both these cancer types have been selected in order to ensure recruitment feasibility in this study, as they are the most frequently treated at the Institut Curie. Study will include 100 patients per cancer type. Semi-structured clinical interviews will be conducted with these patients after they have completed the FCRI. These interviews' analyses will enable us to classify patients according to their FCR levels. Based on this classification, threshold scores for high FCR will be assessed for their sensitivity and specificity for both the 9-item scale and a single item. More in-depths qualitative interviews will be carried out with a random sample of 40 of these patients, stratified by cancer type and stage, in order to explore their perceptions of the disease, the risk of recurrence, their cognitive, emotional and behavioural responses to this risk, and their internal and external psychological resources. Satisfaction will also be assessed with the psychological resources currently available to cope with FCR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | – |
| Breast cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients scoring above a cut-off on the 9-item Fear of cancer recurrence inventory (FRCI) severity scale
Time frame: Within 1 month after inclusion
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.
1 secondary outcome
Emergent themes related to perceptions of cancer, fear of recurrence, psychological responses, and satisfaction with support resources.
Time frame: Within 1 month after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies
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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.
Carole Cagnot contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Breast Cancer, run by Institut Curie at 1 site 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Bredart, Ph.D (+33 1 44 32 43 50, anne.bredart@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients scoring above a cut-off on the 9-item Fear of cancer recurrence inventory (FRCI) severity scale (time frame: Within 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.