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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Therapy-Associated Cancer

Intervention / Treatment
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* Behavioral: Art therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With art therapy<br>Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care | Behavioral: Art therapy<br>* When the patient is placed in a treatment room, a nurse or the ARC proposes to complete the questionnaires corresponding to his visit in accordance with the diagram of the investigations, then retrieve the questionnaire and forward it to the art therapist Then, the art therapist intervenes ans propose different Artistic supports : paint, watercolor pencils, pastels, pencils, clay , origami, music in as an accompaniment to artistic creation. The workshop runs from 30 minutes to 2:30. It can be cut by doctors and nurses interventions during medical care. The limit of care is set at 2:30 for reasons of concentration of the patient, organization of the service but the patient is an actor of his care, and chooses when the session ends. At the end of intervention, the nurse or the ARC proposes at patient to complete the end questionnaire. Theses last are retrieve it and to forward it to the art therapist.<br>|
| No Intervention: Without art therapy<br>6 consecutive sessions of cancer treatments without art therapy with other supportive care added. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution well-being felt | 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. | Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of all items on the ESAS scale along 6 sessions | 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. | 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 | 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. | 6 sessions between 6 weeks to 6 months | 
| evolution of the Fact G quality of life assessment items | 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). | 6 sessions between 6 weeks to 6 months | 
| art therapy satisfaction questionary | 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. | End of 6 session between 6 weeks to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONCOLOGY, ART THERAPY