Breast CancerNCT03873519
Acute Effect of Chromatic Environment During Chemotherapy
A study testing Chromatic Environment and Room Orientation in people with Breast Cancer, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chromatic Environment and Room Orientation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89 years
- Diagnosed with breast cancer that required chemotherapy
- Followed in outpatient clinic
Who cannot join
- Diagnosed color blindness
- Undergoing treatment with antidepressants
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Ruber Internacional
Madrid, 28034
Almudena Corredera, RN, 912986250, almudena.corredera@iob-onco.com
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Chromatic Environment, Room Orientation
- Keywords
- chemotherapy, vital signs, stress, health status, healing environment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromatic EnvironmentOther
Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.
Room OrientationOther
Room will be facing North or South
| Study group | Role | What they receive |
|---|---|---|
| Cold North | Experimental | Group A: Cold color scheme, room facing North Receives: Other: Chromatic Environment; Other: Room Orientation |
| Cold South | Experimental | Group B:Cold color scheme, room facing South Receives: Other: Chromatic Environment; Other: Room Orientation |
| Warm North | Experimental | Group C: Warm color scheme, room facing North Receives: Other: Chromatic Environment; Other: Room Orientation |
| Warm South | Experimental | Group D: Warm color scheme, room facing South Receives: Other: Chromatic Environment; Other: Room Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 5 minutes before to 5 minutes after chemotherapy session
Secondary outcomes (4)
ID-Pain questionnaire
Assessment of neuropathic pain
Measured: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: body temperature
Per standard of care, in Celsius
Measured: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: blood pressure
Per standard of care, in mm Hg
Measured: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: heart rate
Per standard of care, in beats per minute
Measured: 5 minutes before to 5 minutes after chemotherapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Apr 2018
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Oncológico Balselga
- Responsible party
- Principal investigator, Margarita Perez, Universidad Europea de Madrid
- Investigators
- Margarita Pérez Ruiz, MD, PhD, Study chair, Universidad Europea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873519
- Sponsor's protocol ID
- R-2017/UEM11
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31482404
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain
- ClinicalTrials.gov ID
- NCT03873519
- Acronym / sponsor ID
- R-2017/UEM11
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, vital signs, stress, health status, healing environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Instituto Oncológico Balselga
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold North | Experimental | Other: Chromatic Environment, Other: Room OrientationGroup A: Cold color scheme, room facing North |
| Cold South | Experimental | Other: Chromatic Environment, Other: Room OrientationGroup B:Cold color scheme, room facing South |
| Warm North | Experimental | Other: Chromatic Environment, Other: Room OrientationGroup C: Warm color scheme, room facing North |
| Warm South | Experimental | Other: Chromatic Environment, Other: Room OrientationGroup D: Warm color scheme, room facing South |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-89 years
- Diagnosed with breast cancer that required chemotherapy
- Followed in outpatient clinic
Key exclusion criteria (2 listed)
- Diagnosed color blindness
- Undergoing treatment with antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromatic EnvironmentRooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment. | Other | Cold North, Cold South, Warm North, Warm South |
| Room OrientationRoom will be facing North or South | Other | Cold North, Cold South, Warm North, Warm South |
Primary outcome
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.
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.
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.
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.
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.
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
4 secondary outcomes
ID-Pain questionnaire
Time frame: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: body temperature
Time frame: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: blood pressure
Time frame: 5 minutes before to 5 minutes after chemotherapy session
Vital signs: heart rate
Time frame: 5 minutes before to 5 minutes after chemotherapy session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 31482404Gomez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Pérez Ruiz, MD, PhD study chair
Universidad Europea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromatic Environment and Room Orientation in people with Breast Cancer, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Gomez Vela, BS (+34620820447, paulagvela@velasalvadorarquitectos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUROQOL-5D-5L questionnaire: Mobility (time frame: 5 minutes before to 5 minutes after chemotherapy session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.