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

Centre Oscar Lambret

Status: Completed

Conditions: Recurrent Hematologic Cancer; Metastatic Neoplasm

Treatments: Other: questionnaires; Other: questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT01606033

IPSY 0905

Details and patient eligibility

About

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

Full 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

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 4 patient groups

phase II non randomized study

Other group

Description:

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

Treatment:

Other: questionnaire

Other: questionnaires

blind randomized phase II or III study

Other group

Description:

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

Treatment:

Other: questionnaire

Other: questionnaires

open randomized phase II or III study

Other group

Description:

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

Treatment:

Other: questionnaire

Other: questionnaires

receiving standard treatment

Other group

Description:

receiving standard treatment : 120 patients description of patients feeling by questionnaires : -understanding of the implications of participating in a clinical trial

Treatment:

Other: questionnaires