Well-Being, PsychologicalNCT06143189
Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
A study testing Hosting conditions and Hospital Clowns in people with Well-Being, Psychological and Biomarkers, run by University of Coimbra at 3 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Well-Being, Psychological, Biomarkers, Cancer
- What is being tested?
- Hosting conditions and Hospital Clowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesPortugal
- Study dates
- 21 Aug 2020to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women with cancer undergoing chemotherapy in the ambulatory hospital
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.
Coimbra, 3000-075
University of Coimbra - Faculty of Psichology
Coimbra, 3000-115
University of Coimbra - Laboratory of Mitochondrial Biomedicine and Theranostics
Coimbra, 3000-354
About this study
Official title: Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions
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:
Read more
- 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.
Read the detailed description
The recruitment of participants was carried out by a nursing professional in the Portuguese Institute of Oncology of Coimbra, according to the appointments of patients whom would be receiving the usual chemotherapy treatment in ambulatory hospital setting, on the days defined for data and samples collection. Participants were told that they would participate in a study to better understand the variations in the relationships between saliva biomarkers' properties and psychological emotional and attentional states across morning time and those who agree to participate were provided with written informed consent at arrival to ambulatory hospital.
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.
- Being tested
- Hosting conditions, Hospital Clowns
- Keywords
- Well-being, biomarkers, BIOSMILE, psychological functioning, ambulatory cancer chemotherapy, hospital clowns
- Medical subject headings
- Psychological Well-Being, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hosting conditionsOther
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 ClownsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hosting conditions; Other: Hospital Clowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Secondary outcomes (6)
Positive Affect (PA)
Psychological assessment was performed after saliva collection, 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.
Affectivity was assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS has two independent subscales with five items each. Responses are in a Likert scale and can vary from 1 ("Nothing or very slightly") to 5 ("Extremely"). The PANAS can measure affective and mood states in the moment. Higher values in positive affect (PA) and lower values in negative affect (NA) correspond, respectively, to a better affectivity. The Portuguese adaptation showed good psychometric properties, internal consistency (Cronbach's alpha =0.86 for PA) and 0.89 for NA) and structural validity through Confirmatory Factor Analysis.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Negative Affect (NA)
Psychological assessment was performed after saliva collection, 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.
Affectivity was assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS has two independent subscales with five items each. Responses are in a Likert scale and can vary from 1 ("Nothing or very slightly") to 5 ("Extremely"). The PANAS can measure affective and mood states in the moment. Higher values in positive affect (PA) and lower values in negative affect (NA) correspond, respectively, to a better affectivity. The Portuguese adaptation showed good psychometric properties, internal consistency (Cronbach's alpha =0.86 for PA) and 0.89 for NA) and structural validity through Confirmatory Factor Analysis.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Emotional States (PESS)
Psychological assessment was performed after saliva collection, 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.
Emotional States were assessed by the Perception of Emotional States Scale (PESS), based on semantic differential scales and consisting of 8 pairs of opposite adjectives separated by 7 positions (e.g., calm/nervous; happy/sad). These pairs were selected because they represent emotional states, different from the affective states assessed by PANAS. Lower ratings correspond to a better emotional state.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Cognitive and Affective Mindfulness (CAMS-R)
Psychological assessment was performed after saliva collection, 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.
Cognitive and Affective Mindfulness was measured by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), having 9 items rated to a 4-point Likert scale, ranging from 1 (Not at all) to 4 (A lot) and measures mindfulness qualities of attention, tolerance and acceptance of the present moment, with higher values corresponding to better results. For the present study, only 6 items were considered, because of the need to make the psychological assessment as brief as possible so that a minimum interference with ambulatory sessions functioning would occur and respecting the patient's availability could be ensured.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Cognitive functioning (CDT)
Psychological assessment was performed after saliva collection, 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.
Cognitive functioning was assessed by the Clock-Drawing Test (CDT, with higher values corresponding to better cognitive functioning). The CDT measures visuospatial, visuoconstructive and visuomotor capabilities. This test also evaluates other cognitive functions, including language/understanding, memory, attention and executive functions (planning, organization, simultaneous processing, self-monitoring). It is commonly used as a brief cognitive screening test. The Portuguese version of the 18-point quantitative scoring system was used.
Measured: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Satisfaction with HCs' intervention
Satisfaction with HCs' intervention was evaluated in EG through two single items: (1) "Do you think this type of interventions in the hospital is important?", answered on a 4-point Likert scale (ranging between "Very important" and "Nothing important"); and (2) "How satisfied are you with the intervention of the HCs that you just saw?" answered in a 5-point Likert scale (ranging between "Very Satisfied" and "Very Unsatisfied").
Measured: After ~ 90 minutes from basal, during the chemotherapy treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start21 Aug 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese Oncology Institute, Coimbra
- Responsible party
- Principal investigator, Manuela Grazina, University of Coimbra
- Investigators
- Manuela Grazina, Principal investigator, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143189
- Sponsor's protocol ID
- BIOSMILE hospital study
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23518874Casellas-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.
PubMed 32223531Ferreira 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.
PubMed 35461971Chojnowska 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.
PubMed 33535653Matsunaga 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.
PubMed 28683075Picard 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.
PubMed 29339091Steckl 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.
PubMed 30264989Feldman 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.
PubMed 28041836Tijssen, 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.
PubMed 7951753Bioluminescence and chemiluminescence. Methods Enzymol. 1978;57:1-653. No abstract available.
PubMed 732586Babins 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.
PubMed 18938669
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions
- ClinicalTrials.gov ID
- NCT06143189
- Acronym / sponsor ID
- BIOSMILE hospital study
- Keywords
- Well-being, biomarkers, BIOSMILE, psychological functioning, ambulatory cancer chemotherapy, hospital clowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Portuguese Oncology Institute, Coimbra
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The recruitment of participants was carried out by a nursing professional in the Portuguese Institute of Oncology of Coimbra, according to the appointments of patients whom would be receiving the usual chemotherapy treatment in ambulatory hospital setting, on the days defined for data and samples collection. Participants were told that they would participate in a study to better understand the variations in the relationships between saliva biomarkers' properties and psychological emotional and attentional states across morning time and those who agree to participate were provided with written informed consent at arrival to ambulatory hospital.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Other | Other: Hosting conditionsControl Group participants were exposed to the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting. |
| Experimental Group (EG) | Experimental | Other: Hosting conditions, Other: Hospital ClownsExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women with cancer undergoing chemotherapy in the ambulatory hospital
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Hosting conditionsHosting conditions care the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments. | Other | Control Group (CG), Experimental Group (EG) |
| Hospital ClownsThe 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. | Other | Experimental Group (EG) |
Primary outcome
Oxytocin levels (saliva)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
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.
Cortisol levels (saliva)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
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).
Serotonin levels (saliva)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
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.
ATP levels (saliva)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
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.
6 secondary outcomes
Positive Affect (PA)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Negative Affect (NA)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Emotional States (PESS)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Cognitive and Affective Mindfulness (CAMS-R)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Cognitive functioning (CDT)
Time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Satisfaction with HCs' intervention
Time frame: After ~ 90 minutes from basal, during the chemotherapy treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- BackgroundTuckman, B.W., 2012. Manual de investigação em educação: Metodologia para conceber e realizar o processo de investigação científica, 2nd ed. Fundação Calouste Gulbenkian.
- BackgroundGalinha, 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.
- BackgroundTeixeira, 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: PubMed 23518874Santana 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.
- Background: PubMed 32223531Casellas-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.
- Background: PubMed 35461971Ferreira 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.
- Background: PubMed 33535653Chojnowska 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.
- Background: PubMed 28683075Matsunaga 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.
- Background: PubMed 29339091Picard 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.
- Background: PubMed 30264989Steckl 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.
- Background: PubMed 28041836Feldman 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.
- BackgroundTijssen, P. (1985). Practice & Theory of Enzyme Immunoassays. Elsevier, Amsterdam.
- Individual participant dataSharing planned: No
Related trials for Well-Being, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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.
Manuela Grazina principal investigator
University of Coimbra
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hosting conditions and Hospital Clowns in people with Well-Being, Psychological and Biomarkers, run by University of Coimbra at 3 sites in Portugal.
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 1 inclusion and 4 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxytocin levels (saliva) (time frame: Basal and after ~ 90 minutes, during the chemotherapy treatment session). The study lists 4 primary outcomes in all. 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 NCT06143189, which also lists 15 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 22 Nov 2023.