Trial Outcomes & Findings for " Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease" (NCT NCT04195217)

Recruitment via oral information, posters, and flyers in the oncology-hematology day unit. Participation is voluntary with no compensation. After written information and a 24h-7d reflection period, patients sign informed consent. Randomization (1:1) to control or art-therapy group. Follow-up includes questionnaires and medical records. Study lasts 66-68 months, with 6 sessions per patient over 4-6 months.

No participants were excluded prior to allocation, as no issues or protocol deviations were identified during the enrollment process.

Between January 7, 2020, and March 17, 2025, a total of 86 patients were enrolled. Six patients did not receive any chemotherapy session (5 in the art therapy group and 1 in the control group), and 13 were excluded due to insufficient participation. This resulted in an analyzed population of 67 patients: 31 in the art therapy group and 36 in the control group.

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. Well-being (0=well, 10=bad)

For each of the other symptoms of the ESAS scale, : pain, fatigue, nausea, depression, anxiety, drowsiness, lack of appetite, difficulty breathing, 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. For symptoms assessed within the 1st secondary endpoint, the ESAS score correlates positively to symptom intensity.

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. Symptom intensity (0-10) and for well-being a score close to zero means a better result.

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 ( physical, social, emotional and functional). 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). Score global FACT-G (0-108)

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.