Clinical trial NCT04195217: " Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
Official title: " Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Therapy-Associated Cancer
Keywords: ONCOLOGY
ART THERAPY
Lead sponsor: Centre Hospitalier de Perigueux
Sponsor class: OTHER
Collaborators: name: University Hospital, Limoges
First posted: 2019-12-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evolution well-being felt
timeFrame: Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
Secondary outcomes:
measure: evaluation of all items on the ESAS scale along 6 sessions
timeFrame: Before and after each chemotherapy session - 6 sessions between 6 weeks to 6 months
measure: evaluation of all items on the ESAS scale between first and last session
timeFrame: 6 sessions between 6 weeks to 6 months
measure: evolution of the Fact G quality of life assessment items
timeFrame: 6 sessions between 6 weeks to 6 months
measure: art therapy satisfaction questionary
timeFrame: End of 6 session between 6 weeks to 6 months
Other outcomes:
Locations:
city: Perigueux
country: France
facility: Perigueux Hospital Center
state: Dordogne
Study officials:
affiliation: Hospital center of Périgueux
name: Elodie EP BARBUT PAILLARD, SEARCHER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiltz L, Zimoch A. [Using arts therapies in psycho-oncology: evaluation of an exploratory study implemented in an out-patient setting]. Bull Soc Sci Med Grand Duche Luxemb. 2013;(1):48-71. French.
citation: Gotze H, Geue K, Buttstadt M, Singer S, Schwarz R. [Art therapy for cancer patients in outpatient care. Psychological distress and coping of the participants]. Forsch Komplementmed. 2009 Feb;16(1):28-33. doi: 10.1159/000191211. Epub 2009 Jan 30. German.
citation: Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
citation: Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9. doi: 10.1016/j.jpainsymman.2005.07.006.
citation: Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15.
citation: Bruera E, MacMillan K, Hanson J, MacDonald RN. The Edmonton staging system for cancer pain: preliminary report. Pain. 1989 May;37(2):203-209. doi: 10.1016/0304-3959(89)90131-0.
citation: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
citation: Wood MJ, Molassiotis A, Payne S. What research evidence is there for the use of art therapy in the management of symptoms in adults with cancer? A systematic review. Psychooncology. 2011 Feb;20(2):135-45. doi: 10.1002/pon.1722.
citation: Lefevre C, Ledoux M, Filbet M. Art therapy among palliative cancer patients: Aesthetic dimensions and impacts on symptoms. Palliat Support Care. 2016 Aug;14(4):376-80. doi: 10.1017/S1478951515001017. Epub 2015 Nov 20.
citation: Rhondali W, Lasserre E, Filbet M. Art therapy among palliative care inpatients with advanced cancer. Palliat Med. 2013 Jun;27(6):571-2. doi: 10.1177/0269216312471413. No abstract available.
citation: Conroy T, Mercier M, Bonneterre J, Luporsi E, Lefebvre JL, Lapeyre M, Puyraveau M, Schraub S. French version of FACT-G: validation and comparison with other cancer-specific instruments. Eur J Cancer. 2004 Oct;40(15):2243-52. doi: 10.1016/j.ejca.2004.06.010.
citation: Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.