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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology

Conditions
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Lung Cancer, Pancreatic Cancer, Anal Cancer, Anxiety Disorder, Breast Cancer, Depression, Esophageal Cancer, Gallbladder Cancer, Gastric Cancer, Kidney Cancer, Liver Cancer, Small Intestine Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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