Psychological DistressVRAIMENTNCT03905876
Psychological Experience of Discontinuation an Early Phase Treatment by Patients
A study testing Questionnaire in people with Psychological Distress and Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Cancer
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically proven solid cancer locally advanced or metastatic in treatment failure with standard treatments
- Antitumor therapy in an early phase clinical trial
- Comprehension in French sufficient for a good completion of the questionnaires
- Informed consent signed before any specific procedure to study
- Belong to a French social security scheme or equivalent scheme
- Age ≥ 18 years
Who cannot join
- Score <15 on the Montreal Cognitive Assessment (MoCA) test assessing overall cognitive functioning
- Presence of proven psychiatric disorders (eg, mental retardation, psychotic disorders, learning disabilities, attention deficit / hyperactivity disorder, bipolar disorder ...), excluding reactional mood disorders to the experience of the disease, or receiving treatment psychotropic disorder that ability of reasoning, judgment or understanding
- Possibility of benefiting from standard therapeutic options
- Included in an exclusive clinical trial or for which the sponsor has refused to that his trial are associate to the study "VRAIMENT"
- Physical inability to answer questionnaires
- Legal incapacity or limited legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Phase and Role of the Initial prédispositions ( VRAIMENT)
While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).
Read the detailed description
EP trials are crucial in the development of a new cancer treatment. Given the side effects and limited knowledge of any new treatment, the inclusion of patients in this EP faces ethical barriers and communication barriers. This is all the more true as EPs are generally aimed at patients with advanced cancer. Also, faced with these different issues, volunteer patients usually have ambivalent motives. Catt and his collaborators have shown that the primary motivations for agreeing to integrate an early phase are the medical benefits, then the best option available, the maintenance of hope and only then, the aid to research.
And more, at the beginning of a EP trial, most patients simultaneously experience multiple complex symptoms related to their cancer or treatment. These symptoms and their functional consequences generate psychological distress and reduce their quality of life related to health. Measuring psychological distress and quality of life before entering a clinical trial is therefore essential for the analysis of psychopathological processes.
Since emotional regulation involves many aspects, it seems scientifically relevant to choose central scales, which cover broad psychopathological functions, to capture the psychological distress of patients. This battery of scales should include an assessment of levels of anxiety, depression and anger (as markers of irritability) but also pre-morbid psychological predispositions. Indeed, some variables such as resilience and optimism are known to influence the level of psychopathological symptomatology and the experience of cancer. Finally, qualitative interviews would better capture the experience of patients with advanced cancer when they are confronted with an end of treatment in EP.
- Conditions
- Psychological Distress, Cancer
- Being tested
- Questionnaire
- Keywords
- Psychological experience, early clinical trial, initial predisposition
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire to evaluate psychological experience
| Study group | Role | What they receive |
|---|---|---|
| assessment of psychological experience | Other | Questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of anxiety and depression at the end of treatement in an early clinical phase by using the scale HADS (hospital anxiety and depression scale). The range is 0 to 21. The severe anxiety or depression is 21.
Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase
Measured: Approximatey 36 months
Secondary outcomes (9)
Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
Baseline and end of treatment
Measured: Day 1 and approximately 36 months
Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
Baseline and end of treatment
Measured: Day 1 and approximately 36 months
Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory)
Baseline and end of treatment
Measured: Day 1 and approximately 36 months
Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40.
Baseline
Measured: Day 1
Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40.
Baseline
Measured: Day 1
Overall quality of life score assessed by the EORTC (european organization for research and treatment of cancer) questionnaire QLQ-C30 (quality questionnaire)
Baseline and end of treatment
Measured: Day 1 and approximately 36 months
Reason for discontinuation of trial (i.e., intolerable toxicity, disease progression or termination of the protocol as described in the trial)
End of treament
Measured: approximately 36 months
Language markers through 3 main contents: 1/ the experience of the study exit, 2/ the representations of the clinical trial in which the patient participated and 3/ his future.
Baseline and end of treatment
Measured: Day 1 and approximately 36 months
Motivation assessed by using a motivation questionnaire
Baseline
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start21 Jan 2019
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- 182 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean Pierre BLEUSE, Dr, Study director, Insititut régional de Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905876
- Sponsor's protocol ID
- 2018-A02330-55
- Acronym
- VRAIMENT
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22.
PubMed 21098322Bredart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X. Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12.
PubMed 27734561Kroenke K, Johns SA, Theobald D, Wu J, Tu W. Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer. 2013 Mar;21(3):765-73. doi: 10.1007/s00520-012-1578-5. Epub 2012 Sep 1.
PubMed 22941116Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011 Jul;47(10):1490-7. doi: 10.1016/j.ejca.2011.02.020. Epub 2011 Mar 30.
PubMed 21454072Balbuena L, Bowen R, Baetz M, Marwaha S. Mood Instability and Irritability as Core Symptoms of Major Depression: An Exploration Using Rasch Analysis. Front Psychiatry. 2016 Oct 26;7:174. doi: 10.3389/fpsyt.2016.00174. eCollection 2016.
PubMed 27833568Tian J, Hong JS. Assessment of the relationship between resilience and quality of life in patients with digestive cancer. World J Gastroenterol. 2014 Dec 28;20(48):18439-44. doi: 10.3748/wjg.v20.i48.18439.
PubMed 25561814Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.
PubMed 27124466Bozo O, Gundogdu E, Buyukasik-Colak C. The moderating role of different sources of perceived social support on the dispositional optimism-- posttraumatic growth relationship in postoperative breast cancer patients. J Health Psychol. 2009 Oct;14(7):1009-20. doi: 10.1177/1359105309342295.
PubMed 19786527
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Phase and Role of the Initial prédispositions ( VRAIMENT)
- ClinicalTrials.gov ID
- NCT03905876
- Acronym / sponsor ID
- VRAIMENT / 2018-A02330-55
- Conditions
- Psychological Distress, Cancer
- Keywords
- Psychological experience, early clinical trial, initial predisposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 5 Apr 2019 (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.
While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).
Detailed description
EP trials are crucial in the development of a new cancer treatment. Given the side effects and limited knowledge of any new treatment, the inclusion of patients in this EP faces ethical barriers and communication barriers. This is all the more true as EPs are generally aimed at patients with advanced cancer. Also, faced with these different issues, volunteer patients usually have ambivalent motives. Catt and his collaborators have shown that the primary motivations for agreeing to integrate an early phase are the medical benefits, then the best option available, the maintenance of hope and only then, the aid to research.
And more, at the beginning of a EP trial, most patients simultaneously experience multiple complex symptoms related to their cancer or treatment. These symptoms and their functional consequences generate psychological distress and reduce their quality of life related to health. Measuring psychological distress and quality of life before entering a clinical trial is therefore essential for the analysis of psychopathological processes.
Since emotional regulation involves many aspects, it seems scientifically relevant to choose central scales, which cover broad psychopathological functions, to capture the psychological distress of patients. This battery of scales should include an assessment of levels of anxiety, depression and anger (as markers of irritability) but also pre-morbid psychological predispositions. Indeed, some variables such as resilience and optimism are known to influence the level of psychopathological symptomatology and the experience of cancer. Finally, qualitative interviews would better capture the experience of patients with advanced cancer when they are confronted with an end of treatment in EP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of psychological experience | Other | Other: QuestionnaireQuestionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven solid cancer locally advanced or metastatic in treatment failure with standard treatments
- Antitumor therapy in an early phase clinical trial
- Comprehension in French sufficient for a good completion of the questionnaires
- Informed consent signed before any specific procedure to study
- Belong to a French social security scheme or equivalent scheme
Key exclusion criteria (6 listed)
- Score <15 on the Montreal Cognitive Assessment (MoCA) test assessing overall cognitive functioning
- Presence of proven psychiatric disorders (eg, mental retardation, psychotic disorders, learning disabilities, attention deficit / hyperactivity disorder, bipolar disorder ...), excluding reactional mood disorders to the experience of the disease, or receiving treatment psychotropic disorder that ability of reasoning, judgment or understanding
- Possibility of benefiting from standard therapeutic options
- Included in an exclusive clinical trial or for which the sponsor has refused to that his trial are associate to the study "VRAIMENT"
- Physical inability 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 |
|---|---|---|
| QuestionnaireQuestionnaire to evaluate psychological experience | Other | assessment of psychological experience |
Primary outcome
Score of anxiety and depression at the end of treatement in an early clinical phase by using the scale HADS (hospital anxiety and depression scale). The range is 0 to 21. The severe anxiety or depression is 21.
Time frame: Approximatey 36 months
Comparison of the questionnaires collected at the time of inclusion and end of treatment in an early clinical phase
9 secondary outcomes
Anxiety score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
Time frame: Day 1 and approximately 36 months
Depression score obtained by using the HADS subscale (hospital anxiety and depression scale). The range is 0 to 21.
Time frame: Day 1 and approximately 36 months
Anger assessed by using the STAXI-2 questionnaire (stait-trait anger expression inventory)
Time frame: Day 1 and approximately 36 months
Optimism assessed by using the optimism scale (the Life Orientation Test-Revised - LOT-R) . The range is 0 to 40.
Time frame: Day 1
Resilience assessed by using the resilience score (the Connor-Davidson Resilience Scale - CD-RICS-10). The range is 0 to 40.
Time frame: Day 1
Overall quality of life score assessed by the EORTC (european organization for research and treatment of cancer) questionnaire QLQ-C30 (quality questionnaire)
Time frame: Day 1 and approximately 36 months
Reason for discontinuation of trial (i.e., intolerable toxicity, disease progression or termination of the protocol as described in the trial)
Time frame: approximately 36 months
Language markers through 3 main contents: 1/ the experience of the study exit, 2/ the representations of the clinical trial in which the patient participated and 3/ his future.
Time frame: Day 1 and approximately 36 months
Motivation assessed by using a motivation questionnaire
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 21098322Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22.
- Background: PubMed 27734561Bredart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X. Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12.
- Background: PubMed 22941116Kroenke K, Johns SA, Theobald D, Wu J, Tu W. Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer. 2013 Mar;21(3):765-73. doi: 10.1007/s00520-012-1578-5. Epub 2012 Sep 1.
- Background: PubMed 21454072Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011 Jul;47(10):1490-7. doi: 10.1016/j.ejca.2011.02.020. Epub 2011 Mar 30.
- Background: PubMed 27833568Balbuena L, Bowen R, Baetz M, Marwaha S. Mood Instability and Irritability as Core Symptoms of Major Depression: An Exploration Using Rasch Analysis. Front Psychiatry. 2016 Oct 26;7:174. doi: 10.3389/fpsyt.2016.00174. eCollection 2016.
- Background: PubMed 25561814Tian J, Hong JS. Assessment of the relationship between resilience and quality of life in patients with digestive cancer. World J Gastroenterol. 2014 Dec 28;20(48):18439-44. doi: 10.3748/wjg.v20.i48.18439.
- Background: PubMed 27124466Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.
- Background: PubMed 19786527Bozo O, Gundogdu E, Buyukasik-Colak C. The moderating role of different sources of perceived social support on the dispositional optimism-- posttraumatic growth relationship in postoperative breast cancer patients. J Health Psychol. 2009 Oct;14(7):1009-20. doi: 10.1177/1359105309342295.
- 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. This study is not recruiting at the moment.
jean Pierre BLEUSE, Dr study director
Insititut régional de Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Psychological Distress and Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 13 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of anxiety and depression at the end of treatement in an early clinical phase by using the scale HADS (hospital anxiety and depression scale). The range is 0 to 21. The severe anxiety or depression is 21. (time frame: Approximatey 36 months). 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 NCT03905876, which also lists 8 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 13 Feb 2025.