Therapy-Associated Cancer
Conditions
Keywords
ONCOLOGY, ART THERAPY
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.
Interventions
BEHAVIORALArt 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.
Sponsors
Centre Hospitalier de Perigueux
Centre Hospitalier de PAU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The biostatistician will analyze the two arms blindly
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average, Over the 6 Treatment Sessions, of the Change in the ESAS 'Well-being" Assessed Before and After Each Treatment Session. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Difference in ESAS Scores for Each Symptom Between the First Treatment Session and the Last (6th) Session. | 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. |
| Difference in the Total FACT-G Quality-of-life Score Between the First Session and the End of the 6 Anticancer Treatment Sessions. | 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) |
| Participants' Satisfaction With Art Therapy as Well as Their Subjective Perception of the Effects Experienced During and After the Sessions | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORElodie EP BARBUT PAILLARD, SEARCHER
Hospital center of Périgueux
Participant flow
Recruitment details
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.
Pre-assignment details
No participants were excluded prior to allocation, as no issues or protocol deviations were identified during the enrollment process.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12.6 |
| Other supportive care | 28 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 24 Participants |
| Type of cancer Hematologic cancer | 12 Participants |
| Type of cancer Solid cancer | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
None listed