Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Therapy-Associated Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a interventional study at risk and minimal constraints, paramedical, mono-centric, institutional in view of a validation of innovative practices in the care of the patient, excluding health products. It is a superiority, randomized, controlled parallel arms study comparing the usual management and usual care associated with art therapy.Masking: Single (Outcomes Assessor)Masking Description: The biostatistician will analyze the two arms blindlyPrimary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Patients will be randomized into the following groups: Group 1: Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care Group 2: 6 consecutive sessions of cancer treatments with or without additional supportive care. Symptom assessment...

Patients will be randomized into the following groups: Group 1: Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care Group 2: 6 consecutive sessions of cancer treatments with or without additional supportive care. Symptom assessment with the Edmonton Symptom Assessment System (ESAS) is done before and after each treatment session for each patient. The FACT-G questionnaire on the quality of life at the beginning and the end of the care for the two groups (group benefiting from the art-therapy and group not benefiting from the art-therapy) and a questionnaire on the contribution of art therapy, at the end of care, for the participants of the art-therapy group.

Tracking Information

NCT #
NCT04195217
Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Elodie EP BARBUT PAILLARD, SEARCHER Hospital center of Périgueux