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

This study has been terminated.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896467
First received: May 8, 2009
Last updated: July 9, 2013
Last verified: July 2009
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life as assessed by the QLQ-30 questionnaire [ Designated as safety issue: No ]
  • Symptoms of anxiety and depression as assessed by the HADS questionnaire [ Designated as safety issue: No ]
  • Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2007
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No psychotropic treatment, except for antidepressants, anxiolytics, or sleeping pills taken for more than 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896467

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Laboratoire URECA
Villeneuve d'Ascq, France, 59653
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Investigator: Stephanie Clisant Centre Oscar Lambret
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00896467     History of Changes
Other Study ID Numbers: COL-0701, CDR0000626737, COL-IPSY, COL-RCB 2007-A00223-50, INCA-RECF0480
Study First Received: May 8, 2009
Last Updated: July 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
anxiety disorder
depression
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:
Anus Neoplasms
Anxiety Disorders
Breast Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Depression
Depressive Disorder
Esophageal Neoplasms
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Gallbladder Neoplasms
Intestinal Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Mental Disorders
Breast Diseases

ClinicalTrials.gov processed this record on July 20, 2014