Therapy-Associated CancerARONCONCT04195217
" Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
A study testing Art therapy in people with Therapy-Associated Cancer, run by Centre Hospitalier de Perigueux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapy-Associated Cancer
- What is being tested?
- Art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2020to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18
- patient cared for on Onco-hematology day with a cancerous pathology
- consent of the patient
- patient affiliated to social Security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Therapy-Associated Cancer
- Being tested
- Art therapy
- Keywords
- ONCOLOGY, ART THERAPY
- Medical subject headings
- Neoplasms, Second Primary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| With art therapy | Active comparator | Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care Receives: Behavioral: Art therapy |
| Without art therapy | No intervention | 6 consecutive sessions of cancer treatments without art therapy with other supportive care added. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average, Over the 6 Treatment Sessions, of the Change in the ESAS 'Well-being" Assessed Before and After Each Treatment Session.
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)
Measured: Before and after each chimotherapy session - 6 sessions between 6 weeks to 6 months
Secondary outcomes (4)
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
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.
Measured: 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.
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.
Measured: 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.
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)
Measured: 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
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.
Measured: End of 6 session between 6 weeks to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start7 Jan 2020
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Therapy-Associated CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Perigueux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de PAU
- Responsible party
- Principal investigator, Elodie Barbut Paillard, Centre Hospitalier de Perigueux
- Investigators
- Elodie EP BARBUT PAILLARD, SEARCHER, Principal investigator, Hospital center of Périgueux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195217
- Sponsor's protocol ID
- ID-RCB 2018-A03304-51
- Acronym
- ARONCO
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2019
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data sharing characteristics are not yet defined
Publications
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.
PubMed 23808110Gotze 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.
PubMed 19295227Puetz 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.
PubMed 23699646Nainis 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.
PubMed 16488349Geue 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.
PubMed 20688262Bruera 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.
PubMed 2748193Cella 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.
PubMed 8445433Wood 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.
PubMed 20878827Lefevre 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.
PubMed 26584521Rhondali 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.
PubMed 23685771Conroy 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.
PubMed 15454249Bruera 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.
PubMed 1714502
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"
- ClinicalTrials.gov ID
- NCT04195217
- Acronym / sponsor ID
- ARONCO / ID-RCB 2018-A03304-51
- Conditions
- Therapy-Associated Cancer
- Keywords
- ONCOLOGY, ART THERAPY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier de PerigueuxUniversity, hospital or other
- Collaborators
- Centre Hospitalier de PAU
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| With art therapy | Active comparator | Behavioral: Art therapyArt therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care |
| Without art therapy | No intervention | –6 consecutive sessions of cancer treatments without art therapy with other supportive care added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged over 18
- patient cared for on Onco-hematology day with a cancerous pathology
- consent of the patient
- patient affiliated to social Security
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art therapyWhen 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. | Behavioural | With art therapy |
Primary outcome
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)
4 secondary outcomes
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23808110Schiltz 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.
- Background: PubMed 19295227Gotze 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.
- Background: PubMed 23699646Puetz 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.
- Background: PubMed 16488349Nainis 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.
- Background: PubMed 20688262Geue 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.
- Background: PubMed 2748193Bruera 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.
- Background: PubMed 8445433Cella 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.
- Background: PubMed 20878827Wood 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.
- Background: PubMed 26584521Lefevre 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.
- Background: PubMed 23685771Rhondali 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.
- Background: PubMed 15454249Conroy 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.
- Background: PubMed 1714502Bruera 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.
- Quality of life of patients with colorectal cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No. data sharing characteristics are not yet defined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie EP BARBUT PAILLARD, SEARCHER principal investigator
Hospital center of Périgueux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy in people with Therapy-Associated Cancer, run by Centre Hospitalier de Perigueux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195217, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.