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

Cancer Clinical Trial

Official title: Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions

Status Completed

Clinical 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.

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Ambulatory Care
• Biomarkers
• Cancer
• Complementary Therapies

• NCT number: NCT06143189
• Study type: Interventional
• Source: University of Coimbra
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Completion date: August 28, 2020