Clinical trial NCT01606033: Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
Official title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Eligibility criteria: 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 OMS ≤ 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

Primary outcomes:
measure: assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way
timeFrame: 4 years
Secondary outcomes:
measure: evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation
timeFrame: 4 years
measure: measure and compare variation in time of psychological and emotional consequences during treatment
timeFrame: 5 years
measure: measure the level of knowledge on the implications of participating in a clinical trial (case)
timeFrame: 5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
state: Nord Pas de Calais
city: Angers
country: France
facility: Paul PAPIN Center
city: Caen
country: France
facility: François Baclesse Center
city: Cholet
country: France
facility: CHOLET Hospital
city: Dijon
country: France
facility: Georges-François LECLERC Center
city: Lyon
country: France
facility: Léon BERARD Center
city: Montpellier
country: France
facility: Val D'AURELLE Center
city: Reims
country: France
facility: Jean GODINOT Institut
Study officials:
affiliation: Oscar Lambret Center
name: Stéphanie CLISANT
role: STUDY_DIRECTOR
References: