Clinical trial NCT06143189: Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
Official title: Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-Being, Psychological
Biomarkers
Cancer
Ambulatory Care
Complementary Therapies
Keywords: Well-being
biomarkers
BIOSMILE
psychological functioning
ambulatory cancer chemotherapy
hospital clowns
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Portuguese Oncology Institute, Coimbra
First posted: 2023-11-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult women with cancer undergoing chemotherapy in the ambulatory hospital

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxytocin levels (saliva)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Cortisol levels (saliva)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Serotonin levels (saliva)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: ATP levels (saliva)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
Secondary outcomes:
measure: Positive Affect (PA)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Negative Affect (NA)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Emotional States (PESS)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Cognitive and Affective Mindfulness (CAMS-R)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Cognitive functioning (CDT)
timeFrame: Basal and after ~ 90 minutes, during the chemotherapy treatment session
measure: Satisfaction with HCs' intervention
timeFrame: After ~ 90 minutes from basal, during the chemotherapy treatment session
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.
city: Coimbra
country: Portugal
facility: University of Coimbra - Faculty of Psichology
city: Coimbra
country: Portugal
facility: University of Coimbra - Laboratory of Mitochondrial Biomedicine and Theranostics
Study officials:
affiliation: University of Coimbra
name: Manuela Grazina
role: PRINCIPAL_INVESTIGATOR
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