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Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Solid Tumor, Recurrent Hematologic Cancer

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Trial Information

Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials


Inclusion Criteria:



- patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or
targeted therapy evaluated every 2 or 3 cycles; except for clinical trials
associating non drug treatment (radiotherapy, surgery...)

- subject to a 1st, 2nd or 3rd line of antitumor treatment

- a phase 2 open labeled study,

- a phase 2 or 3 blind randomised study,

- a phase 2 or 3 open randomised study,

- a standard treatment non participating to a clinical trial

- male or female patients ≥ 18 years of age

- karnovsky ≥ 70 % or OMS ≤ 2

- recovered from prior toxicities

- social security covered

- written informed consent given

Exclusion Criteria:

- psychiatric disorders, receiving psychotropic treatment

- physical or psychological issues

- forbidden to be included in this study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way

Outcome Description:

quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Stéphanie CLISANT

Investigator Role:

Study Director

Investigator Affiliation:

Oscar Lambret Center

Authority:

France: Committee for the Protection of Personnes

Study ID:

IPSY 0905

NCT ID:

NCT01606033

Start Date:

March 2011

Completion Date:

March 2016

Related Keywords:

  • Metastatic Solid Tumor
  • Recurrent Hematologic Cancer
  • stress
  • Life quality
  • adjustment strategy
  • receiving an antitumor treatment
  • within a clinical trial (case)
  • according to a standard treatment (control)
  • Hematologic Neoplasms

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