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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-11-30

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.

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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).

Conditions

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

Interventions

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questionnaire administration

Intervention Type OTHER

psychosocial assessment and care

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No