Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896467
Recruitment Status : Terminated
First Posted : May 11, 2009
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.

PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

Condition or disease Intervention/treatment
Anal Cancer Anxiety Disorder Breast Cancer Depression Esophageal Cancer Gallbladder Cancer Gastric Cancer Kidney Cancer Liver Cancer Lung Cancer Pancreatic Cancer Small Intestine Cancer Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Detailed Description:



  • To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.


  • To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
  • To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
  • To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.

OUTLINE: This is a multicenter study.

Patients complete four questionnaires, including assessment of symptoms of anxiety and depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of emotional behavior (ERQ), during their first course of treatment, after the first evaluation of treatment effectiveness, and one week after completion of treatment. During their first evaluation, patients also complete a questionnaire on the modalities of randomized clinical trials and their impact on care (ICEC-R).

Study Type : Observational
Estimated Enrollment : 200 participants
Official Title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
Study Start Date : September 2007
Primary Completion Date : September 2010
Study Completion Date : November 2010

Primary Outcome Measures :
  1. Quality of life as assessed by the QLQ-30 questionnaire
  2. Symptoms of anxiety and depression as assessed by the HADS questionnaire
  3. Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed cancer

    • Metastatic disease for which the median progression-free survival is ≥ 4 months
    • Breast, digestive, kidney, lung
  • Receiving first-line antitumor therapy (i.e., chemotherapy or targeted therapy) as part of either:

    • Phase II or III randomized clinical trial
    • Standard treatment off-trial


  • WHO performance status (PS) 0-3 or Karnofsky PS 50-100%
  • No psychological or physical inability to respond to a questionnaire


  • See Disease Characteristics
  • No psychotropic treatment, except for antidepressants, anxiolytics, or sleeping pills taken for more than 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00896467

Centre Oscar Lambret
Lille, France, 59020
Laboratoire URECA
Villeneuve d'Ascq, France, 59653
Sponsors and Collaborators
Centre Oscar Lambret
OverallOfficial: Stephanie Clisant Centre Oscar Lambret Identifier: NCT00896467     History of Changes
Other Study ID Numbers: COL-0701
CDR0000626737 ( Registry Identifier: PDQ (Physician Data Query) )
COL-RCB 2007-A00223-50
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
anxiety disorder
stage IV breast cancer
stage IV renal cell cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
stage IV gastric cancer
stage IV anal cancer
stage IV pancreatic cancer
stage IV esophageal cancer
advanced adult primary liver cancer
unresectable gallbladder cancer
small intestine cancer

Additional relevant MeSH terms:
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Anxiety Disorders
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Anus Neoplasms
Gallbladder Neoplasms
Intestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Mental Disorders