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

Centre Oscar Lambret

Status: Terminated

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

Treatments: Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

Study type: Observational

Funder types: Other

Identifiers

NCT00896467

CDR0000626737 (Registry Identifier)

COL-0701

COL-RCB 2007-A00223-50

INCA-RECF0480

COL-IPSY

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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