Acute Effect of Chromatic Environment During Chemotherapy

NCT03873519 | Unknown

• 1 other identifier: R-2017/UEM11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

chemotherapy; vital signs; stress; health status; healing environment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• ID-Pain questionnaire

  5 minutes before to 5 minutes after chemotherapy session

• Vital signs: body temperature

  5 minutes before to 5 minutes after chemotherapy session

• Vital signs: blood pressure

  5 minutes before to 5 minutes after chemotherapy session

• Vital signs: heart rate

  5 minutes before to 5 minutes after chemotherapy session

Study Arms (4)

Cold North

EXPERIMENTAL

Group A: Cold color scheme, room facing North

Other: Chromatic Environment; Other: Room Orientation

Cold South

EXPERIMENTAL

Group B:Cold color scheme, room facing South

Other: Chromatic Environment; Other: Room Orientation

Warm North

EXPERIMENTAL

Group C: Warm color scheme, room facing North

Other: Chromatic Environment; Other: Room Orientation

Warm South

EXPERIMENTAL

Group D: Warm color scheme, room facing South

Other: Chromatic Environment; Other: Room Orientation

Interventions

Chromatic Environment OTHER

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

Cold North; Cold South; Warm North; Warm South

Room Orientation OTHER

Room will be facing North or South

Cold North; Cold South; Warm North; Warm South

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89 years
• Diagnosed with breast cancer that required chemotherapy
• Followed in outpatient clinic

You may not qualify if:

• Diagnosed color blindness
• Undergoing treatment with antidepressants

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Instituto Oncológico Balselga: collaborator

Study Sites (1)

Hospital Ruber Internacional

Madrid, 28034, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 31482404 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Margarita Pérez Ruiz, MD, PhD

  Universidad Europea

  STUDY CHAIR

Central Study Contacts

Paula Gomez Vela, BS

CONTACT

+34620820447; paulagvela@velasalvadorarquitectos.com

Margarita Pérez Ruiz, MD,PhD

CONTACT

+34649084705; margarita.perez@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: March 13, 2019
• Study Start: April 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

ES (1)