Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Serotonin levels (saliva)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women with cancer undergoing chemotherapy in the ambulatory hospital
排除标准
- •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
结局指标
主要结局
Serotonin levels (saliva)
时间窗: 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.
Cortisol levels (saliva)
时间窗: 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).
Oxytocin levels (saliva)
时间窗: 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.
ATP levels (saliva)
时间窗: 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.
次要结局
- Emotional States (PESS)(Basal and after ~ 90 minutes, during the chemotherapy treatment session)
- Positive Affect (PA)(Basal and after ~ 90 minutes, during the chemotherapy treatment session)
- Satisfaction with HCs' intervention(After ~ 90 minutes from basal, during the chemotherapy treatment session)
- Negative Affect (NA)(Basal and after ~ 90 minutes, during the chemotherapy treatment session)
- Cognitive functioning (CDT)(Basal and after ~ 90 minutes, during the chemotherapy treatment session)
- Cognitive and Affective Mindfulness (CAMS-R)(Basal and after ~ 90 minutes, during the chemotherapy treatment session)
研究者
Manuela Grazina
Professor
University of Coimbra