Acute Effect of Chromatic Environment During Chemotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Chromatic Environment
* Other: Room Orientation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, vital signs, stress, health status, healing environment