Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
NCT ID: NCT06143189
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2020-08-21
2020-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Data were obtained after participants signing informed consent, according to Law no.12/2005, DL no.131/2014 and the Norm 015/2013 of the Directorate-General of Health (DGS), following the Tenets of the Helsinki Declaration. Samples were anonymized following the European Union General Data Protection Regulation (GDPR - EU 2016/679) and the Portuguese Law (Law no.58/2019).
Sociodemographic data, including age, educational level, marital status and profession were obtained by filling in the questionnaire that included the psychological assessment provided by the psychology team members.
This is the first study assessing changes in biomarkers and psychological symptoms in adults with cancer, in particular related to clown performances in treatment rooms. This is a pilot study, in which 64 women were analyzed: experimental group (EG; n=36; HCs intervention plus hosting conditions) versus control group (CG; n=28; hosting conditions). It is important to stress out the novelty of this work, in which a set of well-being biomarkers is implemented, in correlation with psychological evaluation including cognitive function, besides emotional states, all evaluated by cluster analysis.
The psychological assessment protocol covered affective, cognitive and satisfaction aspects of the intervention, in the form of both quantitative and qualitative data. The affective dimension was assessed in both groups using the Emotional States Perception Scale (PESS, with lower values corresponding to a better emotional state), the Positive Affectivity and Negative Affectivity Scale (PANAS, with higher and lower values, respectively, better affectivity), the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R, a measure of attention, tolerance and acceptance of the present moment, with higher values corresponding to better results in these aspects). The cognitive dimension was assessed using the Clock-Drawing Test (CDT, with higher values corresponding to better cognitive functioning). The CDT, as a neuropsychological measure, assesses visuospatial, visuoconstructive and visuomotor abilities. It also involves other cognitive functions, including language/comprehension, memory, attention and executive functions (planning, organization, simultaneous processing, self-monitoring). It is also used as a brief cognitive screening test.
In the post-test, the EG was also assessed in terms of the importance and satisfaction attributed to the HCs intervention, as well as free-explanation testimonies, based on an open question, which finalized the assessment protocol in this group.
Concerning statistical analysis, primarily the qualitative data were described by its absolute and relative frequency while mean ± standard deviation and median \[Quartile 1; Quartile3\] were presented for quantitative data.
A factorial repeated measures ANOVA was applied in order to evaluate either the effect of evaluation moments and group interaction, and the main effect of the repeated measure (although some variables have presented normality deviations on their residuals, that fact did not have a significant impact on lowering power on those analysis). Moreover, bivariate comparisons between evaluations in each group were performed either using a Student's t-test for paired samples or a Wilcoxon test, according to sample distribution, and between groups for each time point using an independent samples t-test or a Mann-Whitney U-test using the same criteria. Pearson and Spearman rank order correlations between pre-test and post-test difference in biomarkers and psychological characteristics were also obtained for each group, and they were evaluated according to each data distribution. Furthermore, the differences of the changes in time of the variables were evaluated in function of the age and educational level of the patients between the two groups using a repeated measures ANOVA considering those as factors in a full factorial model.
These analyses were performed in IBM SPSS, version 25, and were analyzed at a 5% significance level (at a 10% significance level concerning Pearson and Spearman rank order correlations).
In order to assess association between biomarkers and psychological characteristics, cluster analyses using a Manhattan distance with single linkage were performed in Orange version 3.28.0 and the dendrograms obtained were presented.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group (CG)
Control Group participants were exposed to the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.
Hosting conditions
Hosting conditions care
the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.
Experimental Group (EG)
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.
Hosting conditions
Hosting conditions care
the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.
Hospital Clowns
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hosting conditions
Hosting conditions care
the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.
Hospital Clowns
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Portuguese Oncology Institute, Coimbra
OTHER
University of Coimbra
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Manuela Grazina
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manuela Grazina
Role: PRINCIPAL_INVESTIGATOR
University of Coimbra
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.
Coimbra, , Portugal
University of Coimbra - Faculty of Psichology
Coimbra, , Portugal
University of Coimbra - Laboratory of Mitochondrial Biomedicine and Theranostics
Coimbra, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tuckman, B.W., 2012. Manual de investigação em educação: Metodologia para conceber e realizar o processo de investigação científica, 2nd ed. Fundação Calouste Gulbenkian.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tijssen, P. (1985). Practice & Theory of Enzyme Immunoassays. Elsevier, Amsterdam.
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.
Bioluminescence and chemiluminescence. Methods Enzymol. 1978;57:1-653. No abstract available.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIOSMILE hospital study
Identifier Type: -
Identifier Source: org_study_id