CancerCANDYSTRESSNCT06944262
Assessment of Cancer-related Post-traumatic Stress in Patients and Caregivers in the Year Following Diagnosis, and Identification of Their Expectations of Personalized Support - CANDYSTRESS
An observational study of Cancer and Healthcare Professionnals, run by Lille University at 2 sites in France.
Trial summary
The impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Healthcare Professionnals, Caregiver Distress
- How many people
- 350 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Apr 2025to 2 Feb 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: centre oscar lambret
Who may be able to join
- Part 1. Diagnosis of Ca-PTS
- Patient inclusion criteria:
- Male or female, 18 years of age or older,
- recently (<4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center - in accordance with the Cancer Plan),
- with cancer requiring oncological treatment,
- starting oncology treatment at the Oscar Lambret Center,
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- with no Central Nervous System (CNS) metastases,
- with a PRONOPALL score ≤3 (favorable prognosis group, Bourgeois et al., 2017) or expected survival greater than 6 months,
- who have given signed consent to participate in the study and are covered by French social security,
- able to identify a caregiver (i.e., a family member, friend or other person who has helped care for them since diagnosis).
- equipped with a computer or tablet equipped with a webcam and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wants the IGE to be present via video on the computer, if they prefer the video to be made over the phone, in which case they must also be equipped with a smartphone enabling video calls.
- Male or female, 18 years of age or older,
- designated by the patient as their primary caregiver (i.e. "a family member, friend or other person who has helped care for you since diagnosis"),
- have given their signed consent to participate in the study.
- equipped with a computer or tablet equipped with a webcam and an internet connection, for the online questionnaire - the webcam is only necessary if the participant wishes the IGE to be present via video on the computer, if he/she prefers the video to be made over the phone, in which case it is also necessary to be equipped with a smartphone enabling video calls.
- Part 2. Gathering expectations for personalized support and its components.
- In addition, 3 types of focus groups will be set up remote :
- Focus groups with patients from local associations, as well as patient partners of the Oscar Lambret Center and patients from Part 1 if they are interested.
- Men or women of legal age who have or have had cancer,
- Members of a local patient association or of the Oscar Lambret Center's "patient partners" committee,
- Or have participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),
- Equipped with a computer or tablet with camera and internet connection,
- Have given their consent to take part in the study.
- Focus group with caregivers from local associations as well as "partner caregivers" from the Oscar Lambret Center and caregivers from part 1 if they are interested.
- Men or women of full age who are, or have been, caregivers of a cancer patient,
- members of a local caregivers' association,
- or having participated in part 1 (Ca-PTS screening, once the 3 steps have been completed),
- Equipped with a computer or tablet with camera and internet connection,
- Having given their consent to take part in the study.
- Focus groups with hospital medical and paramedical staff as well as non-hospital caregivers involved in the medical in the medical and psychological follow-up of patients.
- Member of the medical and paramedical staff of the Oscar Lambret Center
- Or non-hospital staff involved in the medical or psychological care of patients,
- Professionals not involved in the present study,
- Equipped with a computer or tablet with camera and internet connection
- Having given their consent to participate in the study
Who cannot join
- Part 1. Diagnosis of Ca-PTS
- Non inclusion criteria for patients :
- Patients with meningeal or cerebral metastases,
- Patients with cancer recurrence,
- Patients suffering from a psychiatric or neurological disorder likely to impair their ability to reason or judge (in particular psychotic disorder, autism spectrum disorder, intellectual disability),
- Patients with a psychological or physical incapacity to answer questionnaires, certified by medical staff,
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- Patients subject to a custodial sentence, guardianship or protection of vulnerable adults,
- Presence of CNS metastases (risk of cognitive impairment preventing completion of questionnaires).
- Non-inclusion criteria for caregivers:
- Caregivers suffering from a psychiatric or neurological disorder likely to impair their ability to reason or exercise judgment judgment (in particular psychotic disorder, autism spectrum disorder intellectual disability), or for whom there is a suspicion (not there is a suspicion (no additional examination is prescribed to confirm this criterion, which remains self-declaratory).
- Caregivers with a psychological or physical inability to answer questionnaires, or for whom there is a suspicion suspicion (no further tests are required to confirm this criterion which remains self-reported).
- Caregivers subject to a custodial sentence, guardianship or protection guardianship or protection of vulnerable adults.
- Part 2. Collection of expectations for personalized support and its components.
- Non-inclusion criteria for patients and caregivers who participated in the screening part of the Ca-PTS :
- Failure to complete all measurement times (T0, T1, T2)
- Non-inclusion criteria for focus groups (patients, caregivers): none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Oscar Lambret
Lille, Nord, 59000
Christelle Duprez, PhD, 03 20 41 72 12, christelle.duprez@univ-lille.fr
- Recruiting
Centre Oscar Lambret
Lille, Nord, 5900
Christelle Duprez, PhD, 03 20 41 72 12, christelle.duprez@univ-lille.fr
Nicolas PENEL, MD, PhD
About this study
Official title: Évaluation de la détresse Post-traumatique Relative au Cancer Dans l'année Suivant le Diagnostic Chez Les Patients et Les Aidants et Identification de Leurs Attentes Envers un Accompagnement personnalisé
The impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer recurrence), even before the onset of the disease, patients and their caregivers may have been directly or indirectly confronted with traumatogenic events (e.g., childhood abuse, sudden death). They may therefore be more likely to develop a stress-related mental disorder in their lifetime. The question of the accumulation of traumatic events, the identification of groups of people at risk of developing symptoms of distress, and the management of these symptoms is therefore crucial. In addition, the mutual influence within the patient-caregiver dyad in terms of emotional adjustment, and its evolution throughout the cancer care pathway, are key elements to be considered in these issues.
The CandyStress project is based on a partnership with patients, their caregivers and carers to identify the needs of patient-caregiver dyads at risk of cancer-related post-traumatic stress disorder (Ca-PTS). Longitudinal screening for Ca-PTS in the year following cancer diagnosis will be carried out to identify the characteristics of at-risk dyads who could benefit from long-term support. The aim of this project is to identify the potential need for targeted support and the desired format of this support. This is a preliminary step in identifying needs and the context conducive to the implementation of personalized support, but in no way an evaluation of the effectiveness of an intervention.
- Conditions
- Cancer, Healthcare Professionnals, Caregiver Distress, Caregiver, Caregiver Stress Syndrome
- Keywords
- cancer, trauma, patients, caregivers, dyad, cancer-related post-traumatic stress disorder
- Medical subject headings
- Neoplasms, Wounds and Injuries
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 |
|---|---|---|
| Part 1 - patients groups | (n = 150) = Male or female, 18 years of age or older, recently (<4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center) | |
| Part 1 - caregivers group | (n = 150) = Men or women aged 18 or over, designated by the patient as their primary caregiver (i.e. "a family member, friend or other person who has helped care for you since your diagnosis") | |
| Part 2 - patients | Men or women of legal age who have or have had cancer, Members of a local patient association or of the Oscar Lambret Center's "patient partners" committee. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. | |
| Part 2 - caregivers | Men or women of legal age who are or have been caregivers for a cancer patient, members of a local caregivers' association. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. | |
| Part 2 - healthcare professionals | Medical and paramedical staff at the Oscar Lambret Center Or non-hospital personnel involved in the medical or psychological care of patients, Professionals not involved in the present study. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL5)
total score (0-80) reflects the severity of Post Traumatic Stress Disorder (PTSD) symptoms. A score threshold > 32 has been validated as reflecting probable PTSD
Measured: measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver
Secondary outcomes (14)
self reported general physical condition
answer to the item "How do you feel physically impaired at the moment?" (likert scale from 0: "not at all" to 10: "absolutely")
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
perception of the general physical condition in the other dyad member
answer to the item:: "To what extent do you think your loved one feels physically diminished at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported distress
answer to the item "To what extent do you feel psychologically distressed at the moment? " ((likert scale from 0: "not at all" to 10: "absolutely")
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
perception of the distress in the other dyad member
answer to the item: "To what extent do you think your loved one feels psychologically distressed at the moment? " (likert scale from 0: "not at all" to 10: "absolutely")
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported physical pain (only in patients)
answer to the item "to what extent are you currently experiencing physical pain?" (likert scale from 0: "not at all" to 10: "absolutely")
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
exposure to potentially traumatic events
self reported Life Event Checklist for DSM-5 (LEC-5). The total score is 0 to 48. The higher the score, the more the participant reports traumatic events.
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
post traumatic stress disorder (PTSD)
PTSD checklist for DSM 5 (PCL-5). The total score (0-80) reflects the severity of the PSTD symptoms, and a cut off of 32 a possible PTSD.
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
anxiety symptoms
Generalized Anxiety Disorder (GAD7). The overall score ranges from 0 to 21. Scores of 5, 10 and 15 represent thresholds for mild, moderate and severe anxiety respectively
Measured: : from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
depressive symptoms
Patient Health Questionnaire (PHQ9). The total score ranges from 0 to 27, with a score of 10 or more indicating moderate depression.
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
social support
Social Support Questionnaire SSQ6. Higher SSQ6 scores reflect greater satisfaction with the level of social support.
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
difficulties in emotion regulation
Difficulties in Emotion Regulation Scale Short Form (DERS SF). The higher the score, the greater the difficulty of emotional regulation.
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
resilience
Resilience Resources Scale (RSS). The total score ranges from 12 to 60. Higher scores reflect greater resilience
Measured: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Questions about potential personalized support
Participants will be asked whether they personally feel the need for psychological support to manage their symptoms, and whether they would be willing to engage in such support. If so, they will be asked to specify when they think this support should be offered, and in what form These answers will be collected using open-ended questions.
Measured: baseline
Socio-demographic factors
age, gender, marital status, socio-professional category, level of education
Measured: at inclusion (i.e in the month following the announcement of the cancer treatment) - for patients and caregivers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start2 Apr 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Oscar Lambret, Lille, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944262
- Sponsor's protocol ID
- D2023-02
- Acronym
- CANDYSTRESS
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.
PubMed 25642841Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.
PubMed 27723815
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation de la détresse Post-traumatique Relative au Cancer Dans l'année Suivant le Diagnostic Chez Les Patients et Les Aidants et Identification de Leurs Attentes Envers un Accompagnement personnalisé
- ClinicalTrials.gov ID
- NCT06944262
- Acronym / sponsor ID
- CANDYSTRESS / D2023-02
- Conditions
- Cancer, Healthcare Professionnals, Caregiver Distress, Caregiver, Caregiver Stress Syndrome
- Keywords
- cancer, trauma, patients, caregivers, dyad, cancer-related post-traumatic stress disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Lille UniversityUniversity, hospital or other
- Collaborators
- Centre Oscar Lambret, Lille, France
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 25 Apr 2025 (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 impact of cancer on the lives of patients and their caregivers is undeniable. In addition to the potentially traumatic aspects (i.e., creating a very violent emotional shock) linked to the announcement of the disease and the various stages of the care pathway (effects of treatment, announcement of a cancer recurrence), even before the onset of the disease, patients and their caregivers may have been directly or indirectly confronted with traumatogenic events (e.g., childhood abuse, sudden death). They may therefore be more likely to develop a stress-related mental disorder in their lifetime. The question of the accumulation of traumatic events, the identification of groups of people at risk of developing symptoms of distress, and the management of these symptoms is therefore crucial. In addition, the mutual influence within the patient-caregiver dyad in terms of emotional adjustment, and its evolution throughout the cancer care pathway, are key elements to be considered in these issues.
The CandyStress project is based on a partnership with patients, their caregivers and carers to identify the needs of patient-caregiver dyads at risk of cancer-related post-traumatic stress disorder (Ca-PTS). Longitudinal screening for Ca-PTS in the year following cancer diagnosis will be carried out to identify the characteristics of at-risk dyads who could benefit from long-term support. The aim of this project is to identify the potential need for targeted support and the desired format of this support. This is a preliminary step in identifying needs and the context conducive to the implementation of personalized support, but in no way an evaluation of the effectiveness of an intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - patients groups | – | –(n = 150) = Male or female, 18 years of age or older, recently (<4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center) |
| Part 1 - caregivers group | – | –(n = 150) = Men or women aged 18 or over, designated by the patient as their primary caregiver (i.e. "a family member, friend or other person who has helped care for you since your diagnosis") |
| Part 2 - patients | – | –Men or women of legal age who have or have had cancer, Members of a local patient association or of the Oscar Lambret Center's "patient partners" committee. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. |
| Part 2 - caregivers | – | –Men or women of legal age who are or have been caregivers for a cancer patient, members of a local caregivers' association. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. |
| Part 2 - healthcare professionals | – | –Medical and paramedical staff at the Oscar Lambret Center Or non-hospital personnel involved in the medical or psychological care of patients, Professionals not involved in the present study. For each type of participant (patients, caregivers, healthcare professionals), 3 focus groups will be set up to collect a sufficient amount of data to reach data saturation (Guest et al., 2017; Wilkinson, 2013). In all, 9 focus groups will be set up. Each group will have between 4 and 8 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- centre oscar lambret
Key inclusion criteria (35 listed)
- Part 1. Diagnosis of Ca-PTS
- Male or female, 18 years of age or older,
- recently (<4 months) diagnosed with breast, gynecological, testicular or digestive cancer at the time of the announcement visit (i.e., the announcement to the patient of the treatment plan after the initial multidisciplinary consultation meeting in the cancer center - in accordance with the Cancer Plan),
- with cancer requiring oncological treatment,
- starting oncology treatment at the Oscar Lambret Center,
Key exclusion criteria (16 listed)
- Part 1. Diagnosis of Ca-PTS
- Patients with meningeal or cerebral metastases,
- Patients with cancer recurrence,
- Patients suffering from a psychiatric or neurological disorder likely to impair their ability to reason or judge (in particular psychotic disorder, autism spectrum disorder, intellectual disability),
- Patients with a psychological or physical incapacity to answer questionnaires, certified by medical staff,
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
PTSD Checklist for DSM-5 (PCL5)
Time frame: measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver
total score (0-80) reflects the severity of Post Traumatic Stress Disorder (PTSD) symptoms. A score threshold > 32 has been validated as reflecting probable PTSD
14 secondary outcomes
self reported general physical condition
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
perception of the general physical condition in the other dyad member
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported distress
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
perception of the distress in the other dyad member
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
self reported physical pain (only in patients)
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
exposure to potentially traumatic events
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
post traumatic stress disorder (PTSD)
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
anxiety symptoms
Time frame: : from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
depressive symptoms
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
social support
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
difficulties in emotion regulation
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
resilience
Time frame: from baseline (in the month following the announcement of the cancer treatment) to 6 months and 12 months later
Questions about potential personalized support
Time frame: baseline
Socio-demographic factors
Time frame: at inclusion (i.e in the month following the announcement of the cancer treatment) - for patients and caregivers
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 9 Sep 2026.
- Background: PubMed 25642841Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.
- Background: PubMed 27723815Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Healthcare Professionnals, run by Lille University at 2 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 35 inclusion and 16 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL5) (time frame: measured in the month following the announcement of the cancer treatment, then 6 months and 12 months later - in patients and their caregiver). 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 NCT06944262, which also lists 2 linked publications.
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 9 Sep 2026.