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NCT06143189

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

Completed NA Last updated 22 November 2023
What this trial tests

NA trial testing Hosting conditions in Well-Being, Psychological in 64 participants. Completed in 28 August 2020.

Timeline
21 August 2020
Primary endpoint
28 August 2020
28 August 2020

Quick facts

Lead sponsorUniversity of Coimbra
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment64
Start date21 August 2020
Primary completion28 August 2020
Estimated completion28 August 2020
Sites3 locations across Portugal

Drugs / interventions tested

Conditions studied

Sponsor

University of Coimbra

Who can join

18 and older, female only, with Well-Being, Psychological or Biomarkers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Well-Being, Psychological

Currently open trials in the same condition.

Other University of Coimbra trials

Trials by the same sponsor.

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Data sources for this page

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