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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00896467
• Other study ID #: COL-0701
• Secondary ID: CDR0000626737COL
• Status: Terminated
• Phase: N/A
• First received: May 8, 2009
• Last updated: July 9, 2013
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Depression
• Esophageal Cancer
• Esophageal Neoplasms
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Kidney Cancer
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Laboratoire URECA	Villeneuve d'Ascq

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as assessed by the QLQ-30 questionnaire			No
Primary	Symptoms of anxiety and depression as assessed by the HADS questionnaire			No
Primary	Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires			No