Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-02-28

Brief Summary

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This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

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Detailed Description

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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

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Metastatic Neoplasm Recurrent Hematologic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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phase II non randomized study

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

Group Type OTHER

questionnaires

Intervention Type OTHER

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

questionnaire

Intervention Type OTHER

understanding of the implications of participating in a clinical trial

blind randomized phase II or III study

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

Group Type OTHER

questionnaires

Intervention Type OTHER

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

questionnaire

Intervention Type OTHER

understanding of the implications of participating in a clinical trial

open randomized phase II or III study

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

Group Type OTHER

questionnaires

Intervention Type OTHER

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

questionnaire

Intervention Type OTHER

understanding of the implications of participating in a clinical trial

receiving standard treatment

receiving standard treatment : 120 patients description of patients feeling by questionnaires :

-understanding of the implications of participating in a clinical trial

Group Type OTHER

questionnaires

Intervention Type OTHER

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

Interventions

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questionnaires

Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey

Intervention Type OTHER

questionnaire

understanding of the implications of participating in a clinical trial

Intervention Type OTHER

Eligibility Criteria

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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