Skip to main content
Clinical Trials/NCT04195217
NCT04195217
Unknown
Not Applicable

" Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"

Centre Hospitalier de Perigueux1 site in 1 country86 target enrollmentJanuary 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Therapy-Associated Cancer
Sponsor
Centre Hospitalier de Perigueux
Enrollment
86
Locations
1
Primary Endpoint
Evolution well-being felt
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the impact of art-therapeutic management on a patient with cancer, during chemotherapy treatment, on the reduction of physical or psychological symptoms.

Art therapy is a non-drug approach that can help some patients cope with the consequences of cancer beyond the care provided.

The common psychosocial difficulties experienced by cancer patients are pain, fatigue, depression, anxiety, drowsiness. In sum, the well-being and quality of life of the patient throughout the illness.

The main objective is to evaluate the impact of art therapy, as a supportive care, on improving the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions( around 24 days between 2 sessions) , at patients with a cancer pathology using two questionnaires, one on the evaluation of symptoms (ESAS), the other on the quality of life (FACT-G).

Detailed 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 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.

Registry
clinicaltrials.gov
Start Date
January 7, 2020
End Date
December 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elodie Barbut Paillard

Principal investigator

Centre Hospitalier de Perigueux

Eligibility Criteria

Inclusion Criteria

  • aged over 18
  • patient cared for on Onco-hematology day with a cancerous pathology
  • consent of the patient
  • patient affiliated to social Security

Exclusion Criteria

  • patient minor
  • patient under legal protection
  • patient with too much impairment of vital and / or cognitive functions to participate and understand the study
  • patient whose predictable management is less than the follow-up period (6 sessions),
  • patient who has already participated in an art therapy session during their lifetime

Outcomes

Primary Outcomes

Evolution well-being felt

Time Frame: Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months

The aim is to evaluate the impact of art therapy as a supportive care on the improvement of the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions, in patients having a cancerous pathology. The primary endpoint is the 6-session average of the difference between the ESAS score associated with the patient's well-being symptom (a symptom of "feeling good" on the ESAS assessment), obtained before and after the treatment session. The Edmonton Symptom Assessment System (SESA) is a 9-item symptom rating scale. The quote goes from 0 to 10. A score close to zero means a better result. The comparison of the mean differences between the ESAS score before and after each of the six cancer treatment sessions according to the two randomization groups will be performed using a generalized linear model.

Secondary Outcomes

  • evaluation of all items on the ESAS scale along 6 sessions(Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months)
  • evaluation of all items on the ESAS scale between first and last session(6 sessions between 6 weeks to 6 months)
  • art therapy satisfaction questionary(End of 6 session between 6 weeks to 6 months)
  • evolution of the Fact G quality of life assessment items(6 sessions between 6 weeks to 6 months)

Study Sites (1)

Loading locations...

Similar Trials