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

NCT04195217 | Unknown

• 1 other identifier: ID-RCB 2018-A03304-51
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Therapy-Associated Cancer

Keywords

ONCOLOGY; ART THERAPY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• evaluation of all items on the ESAS scale between first and last session

  6 sessions between 6 weeks to 6 months

• evolution of the Fact G quality of life assessment items

  6 sessions between 6 weeks to 6 months

• art therapy satisfaction questionary

  End of 6 session between 6 weeks to 6 months

Study Arms (2)

With art therapy

ACTIVE COMPARATOR

Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care

Behavioral: Art therapy

Without art therapy

NO INTERVENTION

6 consecutive sessions of cancer treatments without art therapy with other supportive care added.

Interventions

Art therapy BEHAVIORAL

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.

With art therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged over 18
• patient cared for on Onco-hematology day with a cancerous pathology
• consent of the patient
• patient affiliated to social Security

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Perigueux: lead
• University Hospital, Limoges: collaborator

Study Sites (1)

Perigueux Hospital Center

Périgueux, Dordogne, 24000, France

RECRUITING

Related Publications (12)

• 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.

  PMID: 23808110 BACKGROUND

• 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.

  PMID: 19295227 BACKGROUND

• 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.

  PMID: 23699646 BACKGROUND

• 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.

  PMID: 16488349 BACKGROUND

• 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.

  PMID: 20688262 BACKGROUND

• 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.

  PMID: 2748193 BACKGROUND

• 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.

  PMID: 8445433 BACKGROUND

• 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.

  PMID: 20878827 BACKGROUND

• 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.

  PMID: 26584521 BACKGROUND

• 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.

  PMID: 23685771 BACKGROUND

• 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.

  PMID: 15454249 BACKGROUND

• 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.

  PMID: 1714502 BACKGROUND

Related Links

• Quality of life of patients with colorectal cancer

MeSH Terms

Conditions

Neoplasms, Second Primary; Neoplasms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elodie EP BARBUT PAILLARD, SEARCHER

  Hospital center of Périgueux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien SB BOUTREUX, Doctor

CONTACT

(+33)5.53.45.25.25; sebastien.boutreux@ch-perigueux.fr

Elodie EP BARBUT PAILLARD, SEARCHER

CONTACT

elodie.paillard@ch-perigueux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician will analyze the two arms blindly
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: December 11, 2019
• Study Start: January 7, 2020
• Primary Completion: March 17, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)