Acute Effect of Chromatic Environment During Chemotherapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Chromatic Environment; Other: Room Orientation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ruber Internacional
    • Contact: Almudena Corredera, RN; Phone Number: 912986250; Email: almudena.corredera@iob-onco.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cold North; Group A: Cold color scheme, room facing North	Other: Chromatic Environment; Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.; Other: Room Orientation; Room will be facing North or South
EXPERIMENTAL: Cold South; Group B:Cold color scheme, room facing South	Other: Chromatic Environment; Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.; Other: Room Orientation; Room will be facing North or South
EXPERIMENTAL: Warm North; Group C: Warm color scheme, room facing North	Other: Chromatic Environment; Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.; Other: Room Orientation; Room will be facing North or South
EXPERIMENTAL: Warm South; Group D: Warm color scheme, room facing South	Other: Chromatic Environment; Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.; Other: Room Orientation; Room will be facing North or South

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ID-Pain questionnaire	Assessment of neuropathic pain	5 minutes before to 5 minutes after chemotherapy session
Vital signs: body temperature	Per standard of care, in Celsius	5 minutes before to 5 minutes after chemotherapy session
Vital signs: blood pressure	Per standard of care, in mm Hg	5 minutes before to 5 minutes after chemotherapy session
Vital signs: heart rate	Per standard of care, in beats per minute	5 minutes before to 5 minutes after chemotherapy session

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Collaborators: Instituto Oncológico Balselga
• Investigators: Study Chair: Margarita Pérez Ruiz, MD, PhD, Universidad Europea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ANTICIPATED): December 15, 2020
• Study Completion (ANTICIPATED): December 15, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: chemotherapy; stress; vital signs; health status; healing environment
• Other Study ID Numbers: R-2017/UEM11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No