Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
18 Years
N/A
Both
Anal Cancer, Anxiety Disorder, Breast Cancer, Depression, Esophageal Cancer, Gallbladder Cancer, Gastric Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer, Small Intestine Cancer
Trial Information
Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
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).
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Quality of life as assessed by the QLQ-30 questionnaire
Safety Issue:
No
Principal Investigator
Stephanie Clisant
Investigator Affiliation:
Centre Oscar Lambret
Authority:
Unspecified
Study ID:
CDR0000626737
NCT ID:
NCT00896467
Start Date:
September 2007
Completion Date:
Related Keywords:
- Anal Cancer
- Anxiety Disorder
- Breast Cancer
- Depression
- Esophageal Cancer
- Gallbladder Cancer
- Gastric Cancer
- Kidney Cancer
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Small Intestine Cancer
- 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
- Anus Neoplasms
- Anxiety Disorders
- Breast Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Depression
- Depressive Disorder
- Esophageal Diseases
- Esophageal Neoplasms
- Liver Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Gallbladder Neoplasms
- Intestinal Neoplasms
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