Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life

The sample is non-probabilistic, consisting of 56 participants in the control group (CG) and 56 in the experimental group (EG). According to the calculations made for RCT studies (Noordzij et al., 2010), it will take approximately a total of 100 participants (50 participants per group) to detect a 10-point difference between the groups in the result variable QoL (e.g. EORCT QLQ-C30), with a population standard deviation of 15.43, according to previous study data (Lua et al., 2015), assuming a power of 90% and a significance level of 5%. This study contemplates four moments of evaluation: T1 (baseline: 2nd Cycle of CT but before intervention), T2 (6 weeks - 3rd Cycle), T3 (9 weeks - 4th Cycle) and T4 (3 months after the end of the CT). These moments were chosen taking into account the classes of drugs used in the CT. Each cycle has an interval of 21. This is a randomized controlled clinical trial (RCT) being single blind (the participant does not know which group he belongs to, only the investigator) and longitudinal. Intervention procedure: From the 2nd. Chemotherapy cycle (T1), the GC received the standard chemotherapy treatment; while the EG, in addition to the standard chemotherapy treatment, inhaled a hedonic aroma selected at the time of the chemotherapy (among three types of essential oils: bergamot, exotic verbena and geranium). The participant, as she received the CT, would inhale the aroma in a phased manner and under the supervision of the researcher, until the end of the treatment (about two hours). This intervention took place over three cycles of CT (2nd, 3rd and 4th Cycles). Inhalation was carried out using cotton rolls impregnated with the selected oil, since the more directly the odoriferous molecules are applied to the nose, the greater their impact into the organism (Schneider, 2016). However, since it was necessary that the researcher supervised the participants during the inhalation process, the number of times the researcher was in contact with participants from both groups (GC and EG) were the same: 4 times during the chemotherapy treatment to assure the participants from the EG would not have more contacts what could bias the results.