Metastatic NeoplasmIPSYNCT01606033
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
A study testing questionnaires and questionnaire in people with Metastatic Neoplasm and Recurrent Hematologic Cancer, run by Centre Oscar Lambret at 8 sites in France.
Trial summary
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neoplasm, Recurrent Hematologic Cancer
- What is being tested?
- questionnaires and questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 2011to Feb 2014
- 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
- patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)
- subject to a 1st, 2nd or 3rd line of antitumor treatment
- a phase 2 open labeled study,
- a phase 2 or 3 blind randomised study,
- a phase 2 or 3 open randomised study,
- a standard treatment non participating to a clinical trial
Show all 11Show fewer
- male or female patients ≥ 18 years of age
- karnovsky ≥ 70 % or WHO (Performance Status) ≤ 2
- recovered from prior toxicities
- social security covered
- written informed consent given
Who cannot join
- psychiatric disorders, receiving psychotropic treatment
- physical or psychological issues
- forbidden to be included in this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Paul PAPIN Center
Angers, 49033
François Baclesse Center
Caen, 14076
CHOLET Hospital
Cholet, 49300
Georges-François LECLERC Center
Dijon, 21079
Oscar Lambret Center
Lille, Hauts-de-France, 59020
Léon BERARD Center
Lyon, 69373
Val D'AURELLE Center
Montpellier, 34298
Jean GODINOT Institut
Reims, 51056
About this study
Official title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
Read the detailed description
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study
- Conditions
- Metastatic Neoplasm, Recurrent Hematologic Cancer
- Being tested
- questionnaires, questionnaire
- Keywords
- stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)
- Medical subject headings
- Neoplasm Metastasis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
questionnaireOther
understanding of the implications of participating in a clinical trial
| Study group | Role | What they receive |
|---|---|---|
| phase II non randomized study | Other | phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :
* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
* understanding of the implications of participating in a clinical trial Receives: Other: questionnaires; Other: questionnaire |
| blind randomized phase II or III study | Other | blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires :
* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
* understanding of the implications of participating in a clinical trial Receives: Other: questionnaires; Other: questionnaire |
| open randomized phase II or III study | Other | open randomized phase II or III study : 40 patients description of patients feeling by questionnaires : Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey
-understanding of the implications of participating in a clinical trial Receives: Other: questionnaires; Other: questionnaire |
| receiving standard treatment | Other | receiving standard treatment : 120 patients description of patients feeling by questionnaires :
-understanding of the implications of participating in a clinical trial Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)
Measured: 4 years
Secondary outcomes (3)
evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation
adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)
Measured: 4 years
measure and compare variation in time of psychological and emotional consequences during treatment
emotional regulation (DERS 24)
Measured: 5 years
measure the level of knowledge on the implications of participating in a clinical trial (case)
assess impact of it on psychological and emotional experience
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NeoplasmStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie CLISANT, Study director, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606033
- Sponsor's protocol ID
- IPSY-0905
- Other IDs
- 2009-A00221-56
- Acronym
- IPSY
- Status last verified
- Mar 2026
- First submitted
- 23 May 2012
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
- ClinicalTrials.gov ID
- NCT01606033
- Acronym / sponsor ID
- IPSY / IPSY-0905
- Conditions
- Metastatic Neoplasm, Recurrent Hematologic Cancer
- Keywords
- stress, Life quality, adjustment strategy, receiving an antitumor treatment, within a clinical trial (case), according to a standard treatment (control)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 May 2012 (estimated)
- 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.
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.
Detailed description
This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| phase II non randomized study | Other | Other: questionnaires, Other: questionnairephase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires : * Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey * understanding of the implications of participating in a clinical trial |
| blind randomized phase II or III study | Other | Other: questionnaires, Other: questionnaireblind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires : * Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey * understanding of the implications of participating in a clinical trial |
| open randomized phase II or III study | Other | Other: questionnaires, Other: questionnaireopen randomized phase II or III study : 40 patients description of patients feeling by questionnaires : Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey -understanding of the implications of participating in a clinical trial |
| receiving standard treatment | Other | Other: questionnairesreceiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)
- subject to a 1st, 2nd or 3rd line of antitumor treatment
- male or female patients ≥ 18 years of age
- karnovsky ≥ 70 % or WHO (Performance Status) ≤ 2
- recovered from prior toxicities
Key exclusion criteria (3 listed)
- psychiatric disorders, receiving psychotropic treatment
- physical or psychological issues
- forbidden to be included in this study
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 |
|---|---|---|
| questionnairesAnxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey | Other | blind randomized phase II or III study, open randomized phase II or III study, phase II non randomized study, receiving standard treatment |
| questionnaireunderstanding of the implications of participating in a clinical trial | Other | blind randomized phase II or III study, open randomized phase II or III study, phase II non randomized study |
Primary outcome
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
Time frame: 4 years
quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)
3 secondary outcomes
evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation
Time frame: 4 years
measure and compare variation in time of psychological and emotional consequences during treatment
Time frame: 5 years
measure the level of knowledge on the implications of participating in a clinical trial (case)
Time frame: 5 years
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 Mar 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. This study is not recruiting at the moment.
Stéphanie CLISANT study director
Oscar Lambret Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires and questionnaire in people with Metastatic Neoplasm and Recurrent Hematologic Cancer, run by Centre Oscar Lambret at 8 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 11 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way (time frame: 4 years). 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 13 Mar 2026.