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NCT06143189
Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
NA trial testing Hosting conditions in Well-Being, Psychological in 64 participants. Completed in 28 August 2020.
28 August 2020
Quick facts
| Lead sponsor | University of Coimbra |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 64 |
| Start date | 21 August 2020 |
| Primary completion | 28 August 2020 |
| Estimated completion | 28 August 2020 |
| Sites | 3 locations across Portugal |
Drugs / interventions tested
- Hosting conditions
- Hospital Clowns
Conditions studied
- Well-Being, Psychological — all drugs for Well-Being, Psychological →
- Biomarkers — all drugs for Biomarkers →
- Cancer — all drugs for Cancer →
- Ambulatory Care — all drugs for Ambulatory Care →
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.
Verify or expand the search:
- PubMed search for NCT06143189
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06143189 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Coimbra
- Last refreshed: 22 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06143189.
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