Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
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|ClinicalTrials.gov Identifier: NCT00896467|
Recruitment Status : Terminated
First Posted : May 11, 2009
Last Update Posted : July 10, 2013
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|
- 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|
- Quality of life as assessed by the QLQ-30 questionnaire
- Symptoms of anxiety and depression as assessed by the HADS questionnaire
- Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
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 ClinicalTrials.gov identifier (NCT number): NCT00896467
|Centre Oscar Lambret|
|Lille, France, 59020|
|Villeneuve d'Ascq, France, 59653|
|OverallOfficial:||Stephanie Clisant||Centre Oscar Lambret|