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

NCT01606033 | Completed

• 2 other identifiers: IPSY-09052009-A00221-56
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 8

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  4 years

• measure and compare variation in time of psychological and emotional consequences during treatment

  5 years

• measure the level of knowledge on the implications of participating in a clinical trial (case)

  5 years

Study Arms (4)

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

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

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

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

Other: questionnaires

Interventions

questionnaires OTHER

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

blind randomized phase II or III study; open randomized phase II or III study; phase II non randomized study; receiving standard treatment

questionnaire OTHER

understanding of the implications of participating in a clinical trial

blind randomized phase II or III study; open randomized phase II or III study; phase II non randomized study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• psychiatric disorders, receiving psychotropic treatment
• physical or psychological issues
• forbidden to be included in this study

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (8)

Oscar Lambret Center

Lille, Hauts-de-France, 59020, France

Location

Paul PAPIN Center

Angers, 49033, France

Location

François Baclesse Center

Caen, 14076, France

Location

CHOLET Hospital

Cholet, 49300, France

Location

Georges-François LECLERC Center

Dijon, 21079, France

Location

Léon BERARD Center

Lyon, 69373, France

Location

Val D'AURELLE Center

Montpellier, 34298, France

Location

Jean GODINOT Institut

Reims, 51056, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Hematologic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stéphanie CLISANT

  Oscar Lambret Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: March 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)