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Acute Effect of Chromatic Environment During Chemotherapy

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ClinicalTrials.gov Identifier: NCT03873519
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Instituto Oncológico Balselga
Information provided by (Responsible Party):
Margarita Perez, Universidad Europea de Madrid

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Chromatic Environment Other: Room Orientation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. EUROQOL-5D-5L questionnaire: Mobility [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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.

  2. EUROQOL-5D-5L questionnaire: Self-care [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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.

  3. EUROQOL-5D-5L questionnaire: Usual activities [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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.

  4. EUROQOL-5D-5L questionnaire: Pain/Discomfort [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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. EUROQOL-5D-5L questionnaire: Anxiety/Depression [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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.

  6. EUROQOL-5D-5L questionnaire: EQ-VAS [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    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


Secondary Outcome Measures :
  1. ID-Pain questionnaire [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    Assessment of neuropathic pain

  2. Vital signs: body temperature [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    Per standard of care, in Celsius

  3. Vital signs: blood pressure [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    Per standard of care, in mm Hg

  4. Vital signs: heart rate [ Time Frame: 5 minutes before to 5 minutes after chemotherapy session ]
    Per standard of care, in beats per minute



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873519


Contacts
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Contact: Paula Gomez Vela, BS +34620820447 paulagvela@velasalvadorarquitectos.com
Contact: Margarita Pérez Ruiz, MD,PhD +34649084705 margarita.perez@universidadeuropea.es

Locations
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Spain
Hospital Ruber Internacional Recruiting
Madrid, Spain, 28034
Contact: Almudena Corredera, RN    912986250    almudena.corredera@iob-onco.com   
Sponsors and Collaborators
Universidad Europea de Madrid
Instituto Oncológico Balselga
Investigators
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Study Chair: Margarita Pérez Ruiz, MD, PhD Universidad Europea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margarita Perez, Principal Investigator, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03873519     History of Changes
Other Study ID Numbers: R-2017/UEM11
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Perez, Universidad Europea de Madrid:
chemotherapy
vital signs
stress
health status
healing environment