Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143189
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-10
Brief Title:
Well-being Biomarkers BIOSMILE Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
Sponsor:
University of Coimbra
Organization:
University of Coimbra
Study Overview
Official Title:
Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment the Effects of Hospital Clowns and Hosting Conditions
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
The main questions 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 no122005 DL no1312014 and the Norm 0152013 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 2016679 and the Portuguese Law Law no582019
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 n36 HCs intervention plus hosting conditions versus control group CG n28 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 languagecomprehension 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 Students 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 3280 and the dendrograms obtained were presented
Data were obtained after participants signing informed consent according to Law no122005 DL no1312014 and the Norm 0152013 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 2016679 and the Portuguese Law Law no582019
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 n36 HCs intervention plus hosting conditions versus control group CG n28 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 languagecomprehension 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 Students 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 3280 and the dendrograms obtained were presented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None