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

Not Applicable

• Conditions: Therapy-Associated Cancer
• Interventions: Behavioral: Art therapy

• Registration Number: NCT04195217
• Lead Sponsor: Centre Hospitalier de Perigueux

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.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2020-01-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Primary Completion: 2023-03-17
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With art therapy	Art therapy	Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care

Primary Outcome Measures

Name	Time	Method
Evolution well-being felt	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 Outcome Measures

Name	Time	Method
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	Evaluate the impact of art therapy as supportive care on the reduction of ESAS symptoms after one treatment session for 6 sessions.; Secondary endpoint 1, for each of the other symptoms of the ESAS scale, is pain, fatigue, nausea, depression, anxiety, drowsiness, lack of appetite, difficulty breathing, or other symptoms to be discussed by the patient. , the average over 6 treatment sessions, the difference between the ESAS score associated with the symptom studied, obtained before and after each 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.
evaluation of all items on the ESAS scale between first and last session	6 sessions between 6 weeks to 6 months	To determine the impact of the 6 sessions of art therapy as supportive care to cancer treatments on the evolution of symptoms, by the ESAS scale, before the first session of art therapy, and after the last session (6th) The secondary judgment criterion 2 corresponds, for each of the ESAS symptoms, to the difference in ESAS score associated with the symptom studied, before the first and the last treatment session (6th).; 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.
art therapy satisfaction questionary	End of 6 session between 6 weeks to 6 months	Questionnaire (created by the principal investigator) designed to evaluate patient satisfaction, after 6 sessions of art therapy, on this type of therapy as supportive treatment in onco-therapy. It is composed of 5 questions relating to the feeling of art therapy sessions by the patient. They are rated from 0 to 5 (a better score is close to 5) in relation The secondary endpoint 4 is the satisfaction questionnaire for art therapy, performed only in patients in the therapy group by art.
evolution of the Fact G quality of life assessment items	6 sessions between 6 weeks to 6 months	To evaluate the impact of the 6 sessions of art-therapy, as supportive care in onco-therapy, on the evolution of the quality of life.; Secondary endpoint 3 is the difference in total FACT-G quality of life score score between inclusion and the end of the 6 sessions of cancer treatment.; This questionnaire contains 27 items constructed on a Likert scale with 5 coded response modes: 0 "Not at all" / 1 "A little" / 2 "Moderately" / 3 "A lot" / 4 "Enormously".; A score is calculated by dimension. These scores range from 0 to 28 where 0 represents a low level of well-being and 28 a high level of well-being. This score corresponds to the sum of the raw scores obtained for each dimension, and varies from 0 (low level) to 108 (good level of general well-being).

Trial Locations

Locations (1)

Perigueux Hospital Center; 🇫🇷 Perigueux, Dordogne, France