Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life
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|ClinicalTrials.gov Identifier: NCT03585218|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female||Biological: Inhalation of essential oils||Phase 3|
The sample was non-probabilistic, consisting of 51 participants in the control group (CG) and 51 in the experimental group (EG), necessary to detect a difference of 10 points between the groups (standard deviation = 18), in EORCT QLQ- C30, for a power of 80% and a significant level of 5%.
Five moments of evaluation: T0 (baseline: oncology consultation before AQ), T1 (3 weeks after QT onset - 2nd Cycle), T2 (6 weeks - 3rd Cycle), T3 (9 weeks - 4th Cycle) and T4 (3 months upon concluding QT) (Annex 3 - Flowchart). These moments were chosen taking into account the classes of drugs used in AQ. Each cycle has an interregnum of 21 or 14 days, depending on the AQ protocol used. Randomized and controlled clinical study (RCT), single blind (the participant does not know to which group belongs, only the investigator) and longitudinal.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||On each moment of data collection, the researcher will apply the evaluation protocol to the participant regardless of the group. Regarding the psychophysiological variable, each participant's saliva will be collected using salivettes®, while cortisol concentrations will be analyzed through ELISA kits. At baseline, each participant will be provided with three salivettes and an explanatory leaflet so that, on the day before the 2nd Cycle (T1), they can collect their own saliva, around 23 hours before (lowest peak of the cortisol circle), and on the day of the fasting QT, on waking up and thirty minutes after waking up (highest peak of the cortisol circle and assessing reactivity). This process will be replicated throughout the remaining evaluation moments. Subsequently, it is also our goal to evaluate the cortisol levels due to QT by performing one collection of saliva before QT and another thirty minutes after QT.|
|Masking Description:||When a participant is eligible, according to the inclusion criteria, it is allocated to one of the groups, according to the order of entry in the study and with alternation by groups, in a ratio of 1:1.|
|Official Title:||Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Experimental Group
The Experimental Group participants will be submitted to the inhalation of the hedonic aroma during the chemotherapeutic treatment, this being the intervention of the study.The control group is not subject to intervention.
Biological: Inhalation of essential oils
Intervention "Inhalation of essential oils": From the T1 (2nd Cycle QT), Experimental Group Arms will undergo the inhalation of the hedonic aroma selected by them at the time of chemotherapy (among several types of aromas). It is intended that the participant, when receiving the QT, inhales the aroma phase-in and under the investigator's observation until the end of the treatment (about two hours). The inhalation of essential oils will occur using cotton rolls impregnated with the selected oil. The control group is not subject to intervention during chemotherapy treatment.
No Intervention: Control Group
The control group is not subject to intervention.
- Anxiety and depression [ Time Frame: Change in baseline Anxiety and Depression in the 4th cycle of chemotherapy (Time 3 - 63 days after the start of chemotherapy) and follow up (Time 4 - 3 months after chemotherapy ends) ]assessment instruments: Hospital Anxiety and Depression Scale (HADS)
- Distress [ Time Frame: Change in baseline Distress in the 4th cycle of chemotherapy (Time 3 - 63 days after the start of chemotherapy) and follow up (Time 4 - 3 months after chemotherapy ends) ]Emotions Thermometer
- The experimental group presented, in comparison to the control group, lower blood pressure [ Time Frame: Change in the experimental group in the blood pressure of the 1st cycle (each cycle occurs every 21 days) compared to the other cycles of chemotherapy where they inhale the essential oils: up to 63 days. ]blood pressure measurement
- The experimental group presented, in comparison to the control group, lower level of cortisol concentration [ Time Frame: Change in the experimental group in the blood pressure of the 1st cycle (each cycle occurs every 21 days) compared to the other cycles of chemotherapy where they inhale the essential oils: up to 63 days. ]saliva collection and biochemical analysis of cortisol through ELISA kits
- The experimental group presented, in comparison to the control group, lower level of side effects [ Time Frame: Change in baseline QLQ BR23 baseline scores for follow up (3 months after completion of chemotherapy treatment) in the experimental group. ]assessment instruments: the EORTC QLQ-BR23 (European Organisation for Research and Treatment of Cancer - Quality of Life, Module for Breast Cancer). interpretation of the results, the higher the value obtained, lower the quality of life, except in questions 14, 15 and 16 where: the higher the score, the better the quality of life evaluated
- The experimental group presented, in comparison to the control group, lower level of quality of life [ Time Frame: Change in baseline QLQ C30 baseline scores for follow up (3 months after completion of chemotherapy treatment) in the experimental group. ]Assessment instruments: the European Organisation for Research and Treatment of Cancer - Quality of Life (EORTC QLQ-C30). Interpretation of the results, the higher the value obtained, the better the total quality of life - total quality of life result, through weighting formulas carried out by the European Organization for Research and Treatment of Cancer (EORTC) (http://groups.eortc.be/qol/manuals)
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): NCT03585218
|Contact: Marta Pereira, Master||934577699 ext +email@example.com|
|Contact: Graça Pereira, PhD||938471039 ext +firstname.lastname@example.org|
|Viana Do Castelo, Estrada De Santa Luzia, Portugal, 4904-858|
|Contact: António Fradão, graduation 258 802 108 ext +351 email@example.com|
|Contact: Luísa Azevedo, graduation 258 802 100 ext +351 firstname.lastname@example.org|
|Principal Investigator:||Marta Pereira, Master||University of Minho|