CancerCEMA-PNCT06278558
Psychological Factors Influencing Cancer Post-traumatic Growth
A study testing Interviews with a psychologist/psychiatrist in people with Cancer, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Interviews with a psychologist/psychiatrist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2023to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients over 18 years of age
- Patients in the initial phase of curative treatment for a 1st solid cancer
- At the start of neo-adjuvant or adjuvant chemotherapy (1st course or 2nd course)
- At less than 6 months from the initial diagnosis
- Patient having given written consent to participate in the study
Who cannot join
- Patients with a previous history of cancer
- Patients with incurable cancer progression, recurrence or relapse
- Metastatic, brain, hematological or skin cancer
- Patients who have difficulty understanding written French
- Patient psychologically or physically unable to answer questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Valenciennes
Valenciennes, 59300
FODIL Hanane, 0327140665, fodil-h@ch-valenciennes.fr
Anne Sophie Baudry
About this study
Official title: Study of the Psychological Factors Influencing Post-traumatic Growth During Oncological Pathway
The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later.
- Conditions
- Cancer
- Being tested
- Interviews with a psychologist/psychiatrist
- Keywords
- Cancer, Post-traumatic growth, Emotional competence, Emotional distress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews with a psychologist/psychiatristOther
All patients with a high score (≥11) on the HADS anxiety and/or depressive symptoms scale and who are not already receiving known psychological treatment or treatment mentioned in the file will be contacted by telephone by the investigator or a qualified person designated by him/her in order to conduct a telephone interview with the patient and refer him/her to a psychologist or psychiatrist if necessary. The number and percentage of consultations with a psychologist or psychiatrist following this telephone interview will be calculated in order to highlight the benefits of such a practice (HADS assessment + telephone interview with +/- referral) for earlier and easier referral. Depending on the number of patients contacted, consideration may be given to testing the effect of this approach on post-traumatic development.
| Study group | Role | What they receive |
|---|---|---|
| Interviews with a psychologist/psychiatrist | Experimental | Implementation of an interview with a psychologist or psychiatrist following a telephone conversation with patients with no psychological follow-up and a high HADS score (≥11), at all stages of the study (start of chemotherapy T1, end of chemotherapy T2, 6 months after the end of chemotherapy). Receives: Other: Interviews with a psychologist/psychiatrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic growth
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
Measured: T1 : At the beginning of chemotherapy
Post-traumatic growth
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
Measured: T2 : Up to 3 weeks after the end of chemotherapy
Post-traumatic growth
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
Measured: T3 : 6 months after the end of chemotherapy protocol
Secondary outcomes (12)
Satisfaction of supportive care needs
Patients' satisfaction of supportive care needs are assessed using the Supportive Care Needs Survey (SCNS), validated in French (Brédart et al., 2012), comprising 34 items and 5 dimensions (Physical and daily life, psychological and emotional, sexuality, information, care system).
Measured: T1 : At the beginning of chemotherapy
Satisfaction of supportive care needs
Patients' satisfaction of supportive care needs are assessed using the Supportive Care Needs Survey (SCNS), validated in French (Brédart et al., 2012), comprising 34 items and 5 dimensions (Physical and daily life, psychological and emotional, sexuality, information, care system).
Measured: T2 : Up to 3 weeks after the end of chemotherapy
Satisfaction of supportive care needs
Patients' satisfaction of supportive care needs are assessed using the Supportive Care Needs Survey (SCNS), validated in French (Brédart et al., 2012), comprising 34 items and 5 dimensions (Physical and daily life, psychological and emotional, sexuality, information, care system).
Measured: T3 : 6 months after the end of chemotherapy protocol
Emotional competence
Emotional competence are assessed using the Profile of Emotional Competence (S-PEC), validated in French (Baudry et al., 2020), comprising 13 items and 2 dimensions (intrapersonal and interpersonal emotional skills).
Measured: T1 : At the beginning of chemotherapy
Emotional competence
Emotional competence are assessed using the Profile of Emotional Competence (S-PEC), validated in French (Baudry et al., 2020), comprising 13 items and 2 dimensions (intrapersonal and interpersonal emotional skills).
Measured: T2 : Up to 3 weeks after the end of chemotherapy
Emotional competence
Emotional competence are assessed using the Profile of Emotional Competence (S-PEC), validated in French (Baudry et al., 2020), comprising 13 items and 2 dimensions (intrapersonal and interpersonal emotional skills).
Measured: T3 : 6 months after the end of chemotherapy protocol
Anxiety and depression symptoms
Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), validated in French (Razavi et al., 1989), comprising 14 items and 2 dimensions (anxiety and depression).
Measured: T1 : At the beginning of chemotherapy
Anxiety and depression symptoms
Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), validated in French (Razavi et al., 1989), comprising 14 items and 2 dimensions (anxiety and depression).
Measured: T2 : Up to 3 weeks after the end of chemotherapy
Anxiety and depression symptoms
Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), validated in French (Razavi et al., 1989), comprising 14 items and 2 dimensions (anxiety and depression).
Measured: T3 : 6 months after the end of chemotherapy protocol
Psychological flexibility
Psychological flexibility is assessed using the multidimensional psychological flexibility inventory (MPFI-24), validated in French (Grégoire et al., 2020), consisting of 24 items and 2 dimensions (flexibility and inflexibility).
Measured: T1 : At the beginning of chemotherapy
Psychological flexibility
Psychological flexibility is assessed using the multidimensional psychological flexibility inventory (MPFI-24), validated in French (Grégoire et al., 2020), consisting of 24 items and 2 dimensions (flexibility and inflexibility).
Measured: T2 : Up to 3 weeks after the end of chemotherapy
Psychological flexibility
Psychological flexibility is assessed using the multidimensional psychological flexibility inventory (MPFI-24), validated in French (Grégoire et al., 2020), consisting of 24 items and 2 dimensions (flexibility and inflexibility).
Measured: T3 : 6 months after the end of chemotherapy protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start12 Dec 2023
- Primary completionMay 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Collaborators
- Ligue contre le cancer, France, Centre Oscar Lambret, Centre de Cancérologie Les Dentellières, Clinique Teissier, Hôpital Saint Vincent de Paul, Lille
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie Baudry, Principal investigator, CH de Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278558
- Sponsor's protocol ID
- 2023-02-01
- Acronym
- CEMA-P
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Psychological Factors Influencing Post-traumatic Growth During Oncological Pathway
- ClinicalTrials.gov ID
- NCT06278558
- Acronym / sponsor ID
- CEMA-P / 2023-02-01
- Conditions
- Cancer
- Keywords
- Cancer, Post-traumatic growth, Emotional competence, Emotional distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Collaborators
- Ligue contre le cancer, France, Centre Oscar Lambret, Centre de Cancérologie Les Dentellières, Clinique Teissier, Hôpital Saint Vincent de Paul, Lille
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Feb 2024 (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 study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interviews with a psychologist/psychiatrist | Experimental | Other: Interviews with a psychologist/psychiatristImplementation of an interview with a psychologist or psychiatrist following a telephone conversation with patients with no psychological follow-up and a high HADS score (≥11), at all stages of the study (start of chemotherapy T1, end of chemotherapy T2, 6 months after the end of chemotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Patients in the initial phase of curative treatment for a 1st solid cancer
- At the start of neo-adjuvant or adjuvant chemotherapy (1st course or 2nd course)
- At less than 6 months from the initial diagnosis
- Patient having given written consent to participate in the study
Key exclusion criteria (5 listed)
- Patients with a previous history of cancer
- Patients with incurable cancer progression, recurrence or relapse
- Metastatic, brain, hematological or skin cancer
- Patients who have difficulty understanding written French
- Patient psychologically or physically unable to answer questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews with a psychologist/psychiatristAll patients with a high score (≥11) on the HADS anxiety and/or depressive symptoms scale and who are not already receiving known psychological treatment or treatment mentioned in the file will be contacted by telephone by the investigator or a qualified person designated by him/her in order to conduct a telephone interview with the patient and refer him/her to a psychologist or psychiatrist if necessary. The number and percentage of consultations with a psychologist or psychiatrist following this telephone interview will be calculated in order to highlight the benefits of such a practice (HADS assessment + telephone interview with +/- referral) for earlier and easier referral. Depending on the number of patients contacted, consideration may be given to testing the effect of this approach on post-traumatic development. | Other | Interviews with a psychologist/psychiatrist |
Primary outcome
Post-traumatic growth
Time frame: T1 : At the beginning of chemotherapy
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
Post-traumatic growth
Time frame: T2 : Up to 3 weeks after the end of chemotherapy
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
Post-traumatic growth
Time frame: T3 : 6 months after the end of chemotherapy protocol
Post-traumatic growth will be assessed using a 21-item self-report questionnaire and a Likert scale ranging from 0 (Not at all) to 4 (Totally), the Posttraumatic growth inventory (PTGI), which has been revalidated in French (Dubuy et al., 2022) in 4 dimensions: new direction for life (6 items), personal abilities (6 items), spiritual change (2 items) and relationships with others (7 items).
12 secondary outcomes
Satisfaction of supportive care needs
Time frame: T1 : At the beginning of chemotherapy
Satisfaction of supportive care needs
Time frame: T2 : Up to 3 weeks after the end of chemotherapy
Satisfaction of supportive care needs
Time frame: T3 : 6 months after the end of chemotherapy protocol
Emotional competence
Time frame: T1 : At the beginning of chemotherapy
Emotional competence
Time frame: T2 : Up to 3 weeks after the end of chemotherapy
Emotional competence
Time frame: T3 : 6 months after the end of chemotherapy protocol
Anxiety and depression symptoms
Time frame: T1 : At the beginning of chemotherapy
Anxiety and depression symptoms
Time frame: T2 : Up to 3 weeks after the end of chemotherapy
Anxiety and depression symptoms
Time frame: T3 : 6 months after the end of chemotherapy protocol
Psychological flexibility
Time frame: T1 : At the beginning of chemotherapy
Psychological flexibility
Time frame: T2 : Up to 3 weeks after the end of chemotherapy
Psychological flexibility
Time frame: T3 : 6 months after the end of chemotherapy protocol
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 22 Oct 2026.
- 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.
Anne-Sophie Baudry principal investigator
CH de Valenciennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interviews with a psychologist/psychiatrist in people with Cancer, run by Centre Hospitalier de Valenciennes 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 5 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 22 Oct 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-Sophie Baudry (0327140523, baudry-as@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic growth (time frame: T1 : At the beginning of chemotherapy). The study lists 3 primary outcomes in all. 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 22 Oct 2026.