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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Terminated

CT.gov ID

NCT00896467

Collaborator

(none)

200

Enrollment

Locations

Duration (Months)

100

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Cancer Anxiety Disorder Breast Cancer Depression Esophageal Cancer Gallbladder Cancer Gastric Cancer Kidney Cancer Liver Cancer Lung Cancer Pancreatic Cancer Small Intestine Cancer	Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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