Acute Effect of Chromatic Environment During Chemotherapy

NCT ID: NCT03873519

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2020-12-15

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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Cold North

Group A: Cold color scheme, room facing North

Group Type EXPERIMENTAL

Chromatic Environment

Intervention Type OTHER

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Room Orientation

Intervention Type OTHER

Room will be facing North or South

Cold South

Group B:Cold color scheme, room facing South

Group Type EXPERIMENTAL

Chromatic Environment

Intervention Type OTHER

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Room Orientation

Intervention Type OTHER

Room will be facing North or South

Warm North

Group C: Warm color scheme, room facing North

Group Type EXPERIMENTAL

Chromatic Environment

Intervention Type OTHER

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Room Orientation

Intervention Type OTHER

Room will be facing North or South

Warm South

Group D: Warm color scheme, room facing South

Group Type EXPERIMENTAL

Chromatic Environment

Intervention Type OTHER

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Room Orientation

Intervention Type OTHER

Room will be facing North or South

Interventions

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Chromatic Environment

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Intervention Type OTHER

Room Orientation

Room will be facing North or South

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Oncológico Balselga

UNKNOWN

Sponsor Role collaborator

Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Margarita Perez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margarita Pérez Ruiz, MD, PhD

Role: STUDY_CHAIR

Universidad Europea

Locations

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Hospital Ruber Internacional

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Paula Gomez Vela, BS

Role: CONTACT

+34620820447

Margarita Pérez Ruiz, MD,PhD

Role: CONTACT

+34649084705

Facility Contacts

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Almudena Corredera, RN

Role: primary

912986250

References

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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.

Reference Type DERIVED
PMID: 31482404 (View on PubMed)

Other Identifiers

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R-2017/UEM11

Identifier Type: -

Identifier Source: org_study_id

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