Breast Cancer Clinical Trial
Official title:
Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
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.
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).
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