Trial or standard care? study reveals emotional toll on cancer patients
NCT ID NCT01606033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared anxiety, depression, and quality of life between 125 cancer patients who joined clinical trials and those who received standard treatment. Researchers used questionnaires to measure stress and emotional well-being. The goal was to understand how trial participation affects patients' mental health, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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125 people
The number who actually took part.
- Started
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Mar 2011
- Finished
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Feb 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * psychiatric disorders, receiving psychotropic treatment * physical or psychological issues * forbidden to be included in this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHOLET Hospital
Cholet, 49300, France
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François Baclesse Center
Caen, 14076, France
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Georges-François LECLERC Center
Dijon, 21079, France
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Jean GODINOT Institut
Reims, 51056, France
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Léon BERARD Center
Lyon, 69373, France
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Oscar Lambret Center
Lille, Hauts-de-France, 59020, France
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Paul PAPIN Center
Angers, 49033, France
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Val D'AURELLE Center
Montpellier, 34298, France
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Other studies related to the condition(s) this trial covers.
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