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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Kidney Cancer; Breast Cancer; Gastric Cancer; Pancreatic Cancer; Esophageal Cancer; Small Intestine Cancer; Lung Cancer; Anal Cancer; Liver Cancer; Gallbladder Cancer; Anxiety Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Villeneuve d'Ascq, France, 59653
    • Laboratoire URECA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Stephanie Clisant, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (ESTIMATE): May 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; stage IV breast cancer; extensive stage small cell lung cancer; stage IV non-small cell lung cancer; depression; anxiety disorder; stage IV pancreatic cancer; stage IV gastric cancer; stage IV anal cancer; advanced adult primary liver cancer; unresectable gallbladder cancer; stage IV esophageal cancer; small intestine cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Intestinal Diseases; Rectal Diseases; Esophageal Diseases; Colorectal Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Rectal Neoplasms; Anus Diseases; Biliary Tract Neoplasms; Depression; Stomach Neoplasms; Lung Neoplasms; Anxiety Disorders; Pancreatic Neoplasms; Liver Neoplasms; Esophageal Neoplasms; Intestinal Neoplasms; Anus Neoplasms; Gallbladder Neoplasms
• Other Study ID Numbers: COL-0701; CDR0000626737 (REGISTRY: PDQ (Physician Data Query)); COL-IPSY; COL-RCB 2007-A00223-50; INCA-RECF0480