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

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.

Conditions

• Well-Being, Psychological
• Biomarkers
• Cancer
• Ambulatory Care
• Complementary Therapies

Interventions

OTHER

Hosting conditions

Hosting conditions care the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.

OTHER

Hospital Clowns

The HCs "Palhaços D'Opital (PdO)" have a program aiming to bring joy, affection and good mood to adults and elders in hospital environment. They work in pairs, dressed in colorful costumes and they prepared sketches in advance. Their performances recreate day-to-day situations (e.g., clowns trying to install a new TV screen; planning a wedding between the clowns and asking the public for their ideas), ending with specific closure, in order to indicate to the audience that the session had finished and to promote a positive environment after their departure. Each intervention lasted around 15 minutes.

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra

  collaborator OTHER

• University of Coimbra

  lead OTHER

Principal Investigators

• Manuela Grazina · University of Coimbra

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-21

Primary Completion

2020-08-28

Completion

2020-08-28

Countries

• Portugal

Study Locations