Clinical trial NCT00896467: 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
Overall status: TERMINATED
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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).

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

Primary outcomes:
measure: Quality of life as assessed by the QLQ-30 questionnaire
measure: Symptoms of anxiety and depression as assessed by the HADS questionnaire
measure: Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Villeneuve d'Ascq
country: France
facility: Laboratoire URECA
Study officials:
affiliation: Centre Oscar Lambret
name: Stephanie Clisant
References: