Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
Primary Purpose
Anal Cancer, Anxiety Disorder, Breast Cancer
Status
Terminated
Phase
Locations
France
Study Type
Observational
Intervention
questionnaire administration
psychosocial assessment and care
quality-of-life assessment
Sponsored by
About this trial
This is an observational trial for Anal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Centre Oscar Lambret
- Laboratoire URECA
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00896467
Brief Title
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
Official Title
Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
Study Type
Observational
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Anxiety Disorder, Breast Cancer, Depression, Esophageal Cancer, Gallbladder Cancer, Gastric Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer, Small Intestine Cancer
Keywords
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
7. Study Design
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life as assessed by the QLQ-30 questionnaire
Title
Symptoms of anxiety and depression as assessed by the HADS questionnaire
Title
Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Clisant
Organizational Affiliation
Centre Oscar Lambret
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Laboratoire URECA
City
Villeneuve d'Ascq
ZIP/Postal Code
59653
Country
France
12. IPD Sharing Statement
Learn more about this trial
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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