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

• 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 ]
  

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).