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

Last updated on July 2021

Recruitment

Recruitment Status: Active, not recruiting
Estimated Enrollment: 110

Summary

Conditions: Breast Cancer - Female
Type: Interventional
Phase: Not Applicable
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: On each moment of data collection, the researcher will apply the evaluation protocol to the participant regardless of the group and before chemotherapy treatment. Regarding the psychophysiological variable, each participant's saliva will be collected using salivettes®, while cortisol concentrations will be analyzed through ELISA kits. At the time of the sample collection, before the CT, the participant who accepted to participate and fulfilled the inclusion criteria will be provided with three salivettes and an explanatory leaflet so that, on the day before the 2nd Cycle, they can collect their own saliva, around 23h, and on the day of CT, on waking up and thirty minutes after, fasting. This process will be replicated throughout the remaining evaluation moments. Subsequently, it is also our goal to evaluate the cortisol levels to CT by performing one collection of saliva before and another thirty minutes after CT.Masking: Single (Participant)Masking Description: When a participant is eligible, according to the inclusion criteria, she is allocated to one of the groups in a 1:1 ratio. The randomization assignment was placed in sealed envelopes and assigned before chemotherapy (CT).Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Only males

Description

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.

Tracking Information

NCT #: NCT03585218
Collaborators: Foundation for Science and Technology, Portugal
Investigators: Principal Investigator: Marta Pereira, Master University of Minho