Acute Effect of Chromatic Environment During Chemotherapy

Breast Cancer Clinical Trial

Official title:

Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873519
• Other study ID #: R-2017/UEM11
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2020
• Source: Universidad Europea de Madrid
• Contact: Paula Gomez Vela, BS
• Phone: +34620820447
• Email: paulagvela[@]velasalvadorarquitectos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Chromatic Environment
Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.
• Room Orientation
Room will be facing North or South

Locations

Country	Name	City	State
Spain	Hospital Ruber Internacional	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	Instituto Oncológico Balselga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EUROQOL-5D-5L questionnaire: Mobility	The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.	5 minutes before to 5 minutes after chemotherapy session
Primary	EUROQOL-5D-5L questionnaire: Self-care	The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.	5 minutes before to 5 minutes after chemotherapy session
Primary	EUROQOL-5D-5L questionnaire: Usual activities	The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.	5 minutes before to 5 minutes after chemotherapy session
Primary	EUROQOL-5D-5L questionnaire: Pain/Discomfort	The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.	5 minutes before to 5 minutes after chemotherapy session
Primary	EUROQOL-5D-5L questionnaire: Anxiety/Depression	The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.	5 minutes before to 5 minutes after chemotherapy session
Primary	EUROQOL-5D-5L questionnaire: EQ-VAS	The EQ VAS is an independent subscale of the EUROQOL-5D-5L questionnaire, which uses a vertical visual analogue scale format. The EQ VAS is used for recording the self-rated health on a range from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement	5 minutes before to 5 minutes after chemotherapy session
Secondary	ID-Pain questionnaire	Assessment of neuropathic pain	5 minutes before to 5 minutes after chemotherapy session
Secondary	Vital signs: body temperature	Per standard of care, in Celsius	5 minutes before to 5 minutes after chemotherapy session
Secondary	Vital signs: blood pressure	Per standard of care, in mm Hg	5 minutes before to 5 minutes after chemotherapy session
Secondary	Vital signs: heart rate	Per standard of care, in beats per minute	5 minutes before to 5 minutes after chemotherapy session