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

August 24, 2026 updated by: Elodie Barbut Paillard, Centre Hospitalier de Perigueux

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Dordogne
      • Périgueux, Dordogne, France, 24000
        • Perigueux Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With art therapy
Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care
Behavioral: Art therapy

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.
No Intervention: Without art therapy
6 consecutive sessions of cancer treatments without art therapy with other supportive care added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average, Over the 6 Treatment Sessions, of the Change in the ESAS 'Well-being" Assessed Before and After Each Treatment Session.
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.

Well-being (0=well, 10=bad)
Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Over the 6 Treatment Sessions of the Difference Between ESAS Scores for Each One of the Other Symptoms, Measured Before and After Each Treatment Session
Time Frame: Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months

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.
Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months
Difference in ESAS Scores for Each Symptom Between the First Treatment Session and the Last (6th) Session.
Time Frame: 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. Symptom intensity (0-10) and for well-being a score close to zero means a better result.
6 sessions between 6 weeks to 6 months
Difference in the Total FACT-G Quality-of-life Score Between the First Session and the End of the 6 Anticancer Treatment Sessions.
Time Frame: 6 sessions between 6 weeks to 6 months

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)
6 sessions between 6 weeks to 6 months
Participants' Satisfaction With Art Therapy as Well as Their Subjective Perception of the Effects Experienced During and After the Sessions
Time Frame: 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.
End of 6 session between 6 weeks to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Perigueux

Collaborators

Centre Hospitalier de PAU

Investigators

  • Principal Investigator: Elodie EP BARBUT PAILLARD, SEARCHER, Hospital center of Périgueux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Actual)

March 17, 2025

Study Completion (Actual)

March 17, 2025

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-RCB 2018-A03304-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data sharing characteristics are not yet defined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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