Clinical trial NCT03873519: Acute Effect of Chromatic Environment During Chemotherapy
Official title: Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: chemotherapy
vital signs
stress
health status
healing environment
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Instituto Oncológico Balselga
First posted: 2019-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South), and they will be assigned a new condition at each next visit. The sequence will be assigned randomly to each patient. During each of the four visits, the patients will be treated per standard of care during their chemotherapy sessions. Outcome variables will be assessed before and after each visit.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to examine the acute effect of color, room orientation (affecting amount of luminosity) on perceived health status and stress levels in oncologic patients during chemotherapy sessions at outpatient clinic. The secondary objectives will be to study the effect on vital signs (body temperature, heart rate, systolic blood pressure). Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South) for each session. For the next session, patients will be assigned a new condition. Assignment of sequences will be randomized for each patient.

20 patients will be randomly assigned to one of the four groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be treated per standard of care.


Eligibility criteria: Inclusion criteria:

* Age 18-89 years
* Diagnosed with breast cancer that required chemotherapy
* Followed in outpatient clinic

Exclusion criteria:

* Diagnosed color blindness
* Undergoing treatment with antidepressants

Primary outcomes:
measure: EUROQOL-5D-5L questionnaire: Mobility
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: EUROQOL-5D-5L questionnaire: Self-care
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: EUROQOL-5D-5L questionnaire: Usual activities
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: EUROQOL-5D-5L questionnaire: Pain/Discomfort
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: EUROQOL-5D-5L questionnaire: Anxiety/Depression
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: EUROQOL-5D-5L questionnaire: EQ-VAS
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
Secondary outcomes:
measure: ID-Pain questionnaire
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: Vital signs: body temperature
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: Vital signs: blood pressure
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
measure: Vital signs: heart rate
timeFrame: 5 minutes before to 5 minutes after chemotherapy session
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
Study officials:
affiliation: Universidad Europea
name: Margarita Pérez Ruiz, MD, PhD
role: STUDY_CHAIR
References:
citation: Gomez-Vela P, Perez-Ruiz M, Hernandez Martin MF, Roman J, Larumbe-Zabala E. Acute effect of orange chromatic environment on perceived health status, pain, and vital signs during chemotherapy treatment. Support Care Cancer. 2020 May;28(5):2321-2329. doi: 10.1007/s00520-019-05064-w. Epub 2019 Sep 3.