Breast Cancer
Conditions
Keywords
chemotherapy, vital signs, stress, health status, healing environment
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.
Interventions
OTHERChromatic Environment
Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.
OTHERRoom Orientation
Room will be facing North or South
Sponsors
Instituto Oncológico Balselga
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EUROQOL-5D-5L questionnaire: EQ-VAS | 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 |
| EUROQOL-5D-5L questionnaire: Self-care | 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 | 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 | 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 | 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: Mobility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs: body temperature | 5 minutes before to 5 minutes after chemotherapy session | Per standard of care, in Celsius |
| Vital signs: blood pressure | 5 minutes before to 5 minutes after chemotherapy session | Per standard of care, in mm Hg |
| Vital signs: heart rate | 5 minutes before to 5 minutes after chemotherapy session | Per standard of care, in beats per minute |
| ID-Pain questionnaire | 5 minutes before to 5 minutes after chemotherapy session | Assessment of neuropathic pain |
Countries
Spain
Contacts
Primary ContactPaula Gomez Vela, BS
Backup ContactMargarita Pérez Ruiz, MD,PhD
Outcome results
None listed