Therapy-Associated Cancer Clinical Trial
— ARONCOOfficial title:
" Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
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).
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 31, 2023 |
Est. primary completion date | March 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Perigueux Hospital Center | Perigueux | Dordogne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Perigueux | University Hospital, Limoges |
France,
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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation
Götze H, Geue K, Buttstädt 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. — View Citation
Lefèvre 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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