Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects

NCT06143189 | Completed

• 1 other identifier: BIOSMILE hospital study
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this interventional study is to evaluate the impact of Hospital Clowns (HCs) intervention, besides to hospital hosting conditions, in the well-being of adult female patients during ambulatory chemotherapy. The main question\[s\] it aims to answer are:

• Do the short-term HCs interventions during ambulatory chemotherapy may increase well-being of adult cancer patients in comparison to the hospital hosting conditions?
• Do the short-term HCs interventions, besides the hospital hosting conditions, have effects on well-being biomarkers in association with psychological outcomes? Participants self-collect a sample of saliva followed by psychological assessment, at a first time-point (basal) and at a final time-point (\~after 90 minutes of basal) (pre- and post-test), during the chemotherapy treatment session. Researchers have compared an HCs intervention plus hosting conditions - experimental group, EG, and hosting conditions only - control group, CG, by the repeated measures of pre- and post-test of biomarkers in saliva and the psychological functioning evaluations, to see the degree of the impact of HCs intervention in the well-being of the patients in comparison with normal hosting conditions. Each HCs intervention lasts around 15 minutes, and it is performed in the middle of the procedure between pre- and post-test.

Conditions

Well-Being, Psychological; Biomarkers; Cancer; Ambulatory Care; Complementary Therapies

Keywords

Well-being; biomarkers; BIOSMILE; psychological functioning; ambulatory cancer chemotherapy; hospital clowns

Outcome Measures

Primary Outcomes (4)

• Oxytocin levels (saliva)

  Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test). The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG. Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL), and stored at 4°C. The evaluation of oxytocin levels was performed by using the colorimetric competitive enzyme immunoassay ELISA kit ADI-900-153A (Enzo Life Sciences). Oxytocin extraction was required prior to ELISA, using SPE columns, acetonitrile and trifluoroacetic acid, according to manufacturers' instructions. All the samples were analyzed in duplicate, the saliva oxytocin content was expressed in pg/mL, determined by plotting the optical density of each sample against the standard curve.

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Cortisol levels (saliva)

  Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test). The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG. Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL). The samples were collected according to the schedule as described above and stored at 4°C. The evaluation of cortisol levels was performed by using the colorimetric competitive enzyme immunoassay ELISA kit ADI-900-071 (Enzo Life Sciences). The samples were thawed and centrifuged for immediate immunoassay processing in duplicate. A standard curve was used to estimate the cortisol content (pg/mL).

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Serotonin levels (saliva)

  Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test). The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG. Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL) and stored at 4°C. In the serotonin determination, samples were concentrated by lyophilization. The samples were frozen in liquid nitrogen and then processed in a freeze dryer. The serotonin ELISA assay was performed using a colorimetric competitive enzyme immunoassay (ADI-900-175 (Enzo Life Sciences)) kit, following to manufacturers' directions. The optical density (OD) was red at λ=405nm and the serotonin content (ng/mL) was determined by plotting OD of each sample against the standard curve.

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• ATP levels (saliva)

  Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test). The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes made between the baseline (pre-test) and after \~90 minutes (post-test) in the EG. Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL), according to the schedule described and stored at 4°C. The assessment of the saliva ATP levels was performed using a bioluminescent assay (ATP Bioluminescence Assay Kit HS II, Roche Diagnostics). This technique uses the ATP dependence on oxidation catalyzed by luciferase and allows the measurement of extremely low concentrations of ATP (up to 10-15 mol) in the saliva samples. The protein concentration was assayed by the Bradford method, and ATP levels were expressed normalized to that concentration.

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

Secondary Outcomes (6)

• Positive Affect (PA)

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Negative Affect (NA)

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Emotional States (PESS)

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Cognitive and Affective Mindfulness (CAMS-R)

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

• Cognitive functioning (CDT)

  Basal and after ~ 90 minutes, during the chemotherapy treatment session

Study Arms (2)

Control Group (CG)

OTHER

Control Group participants were exposed to the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.

Other: Hosting conditions

Experimental Group (EG)

EXPERIMENTAL

Experimental Group participants were exposed to the Hospital Clowns intervention plus the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.

Other: Hosting conditions; Other: Hospital Clowns

Interventions

Hosting conditions OTHER

Hosting conditions care the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.

Control Group (CG); Experimental Group (EG)

Hospital Clowns OTHER

The HCs "Palhaços D'Opital (PdO)" have a program aiming to bring joy, affection and good mood to adults and elders in hospital environment. They work in pairs, dressed in colorful costumes and they prepared sketches in advance. Their performances recreate day-to-day situations (e.g., clowns trying to install a new TV screen; planning a wedding between the clowns and asking the public for their ideas), ending with specific closure, in order to indicate to the audience that the session had finished and to promote a positive environment after their departure. Each intervention lasted around 15 minutes.

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women were included in order to avoid gender based bias, concerning well being biomarkers. Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women with cancer undergoing chemotherapy in the ambulatory hospital

You may not qualify if:

• Patients with head and neck cancer
• Having their first or last chemotherapy session
• Receiving chemotherapy orally or via lumbar puncture
• Presenting with any cognitive or language impairment that would prevent their understanding of the study and assessment or that could predictably interfere the levels of biomarkers evaluated

Sponsors & Collaborators

• University of Coimbra: lead
• Portuguese Oncology Institute, Coimbra: collaborator

Study Sites (3)

Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.

Coimbra, 3000-075, Portugal

Location

University of Coimbra - Faculty of Psichology

Coimbra, 3000-115, Portugal

Location

University of Coimbra - Laboratory of Mitochondrial Biomedicine and Theranostics

Coimbra, 3000-354, Portugal

Location

Related Publications (15)

• Tuckman, B.W., 2012. Manual de investigação em educação: Metodologia para conceber e realizar o processo de investigação científica, 2nd ed. Fundação Calouste Gulbenkian.

  BACKGROUND

• Galinha, I.C., Pereira, C.R., Esteves, F., 2014. Versão reduzida da escala portuguesa de afeto positivo e negativo - PANAS-VRP: Análise fatorial confirmatória e invariância temporal [Short-Form of the Portuguese version of the positive and negative affect schedule - PANAS-Port-VRP: Confirmatory factorial analysis and temporal invariance]. Psicologia. 28 (1), 53-65. http://scielo.pt/scielo.php?script=sci_arttext&pid=S0874-20492014000100005&lng=pt&tlng=pt.

  BACKGROUND

• Teixeira, R.J., Ferreira, G., Pereira, M.G., 2017. Portuguese validation of the Cognitive and Affective. Mindfulness & Compassion. 2, 3-8. https://doi.org/10.1016/J.MINCOM.2017.03.001.

  BACKGROUND

• Santana I, Duro D, Freitas S, Alves L, Simoes MR. The Clock Drawing Test: Portuguese norms, by age and education, for three different scoring systems. Arch Clin Neuropsychol. 2013 Jun;28(4):375-87. doi: 10.1093/arclin/act016. Epub 2013 Mar 21.

  PMID: 23518874 BACKGROUND

• Casellas-Grau A, Ochoa C, Lleras De Frutos M, Flix-Valle A, Rosales A, Gil F. Perceived changes in psychological and physical symptoms after hospital clown performances in a cancer setting. Arts Health. 2021 Jun;13(2):189-203. doi: 10.1080/17533015.2020.1744172. Epub 2020 Mar 29.

  PMID: 32223531 BACKGROUND

• Ferreira AC, Osorio FL. Peripheral oxytocin concentrations in psychiatric disorders - A systematic review and methanalysis: Further evidence. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jul 13;117:110561. doi: 10.1016/j.pnpbp.2022.110561. Epub 2022 Apr 21.

  PMID: 35461971 BACKGROUND

• Chojnowska S, Ptaszynska-Sarosiek I, Kepka A, Knas M, Waszkiewicz N. Salivary Biomarkers of Stress, Anxiety and Depression. J Clin Med. 2021 Feb 1;10(3):517. doi: 10.3390/jcm10030517.

  PMID: 33535653 BACKGROUND

• Matsunaga M, Ishii K, Ohtsubo Y, Noguchi Y, Ochi M, Yamasue H. Association between salivary serotonin and the social sharing of happiness. PLoS One. 2017 Jul 6;12(7):e0180391. doi: 10.1371/journal.pone.0180391. eCollection 2017.

  PMID: 28683075 BACKGROUND

• Picard M, McEwen BS, Epel ES, Sandi C. An energetic view of stress: Focus on mitochondria. Front Neuroendocrinol. 2018 Apr;49:72-85. doi: 10.1016/j.yfrne.2018.01.001. Epub 2018 Jan 12.

  PMID: 29339091 BACKGROUND

• Steckl AJ, Ray P. Stress Biomarkers in Biological Fluids and Their Point-of-Use Detection. ACS Sens. 2018 Oct 26;3(10):2025-2044. doi: 10.1021/acssensors.8b00726. Epub 2018 Oct 16.

  PMID: 30264989 BACKGROUND

• Feldman R. The Neurobiology of Human Attachments. Trends Cogn Sci. 2017 Feb;21(2):80-99. doi: 10.1016/j.tics.2016.11.007. Epub 2016 Dec 30.

  PMID: 28041836 BACKGROUND

• Tijssen, P. (1985). Practice & Theory of Enzyme Immunoassays. Elsevier, Amsterdam.

  BACKGROUND

• Kruger NJ. The Bradford method for protein quantitation. Methods Mol Biol. 1994;32:9-15. doi: 10.1385/0-89603-268-X:9. No abstract available.

  PMID: 7951753 BACKGROUND

• Bioluminescence and chemiluminescence. Methods Enzymol. 1978;57:1-653. No abstract available.

  PMID: 732586 BACKGROUND

• Babins L, Slater ME, Whitehead V, Chertkow H. Can an 18-point clock-drawing scoring system predict dementia in elderly individuals with mild cognitive impairment? J Clin Exp Neuropsychol. 2008 Feb;30(2):173-86. doi: 10.1080/13803390701336411.

  PMID: 18938669 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Neoplasms

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Manuela Grazina

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: August 21, 2020
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)