Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- University of Minho
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Breast cancer is a major public health problem and is the main cancer disease in women worldwide and in Europe. In Portugal it is the most common cancer, the third cause of cancer death, following the European trend.
Breast cancer (BC) triggers a myriad of physical and psychosocial stressors with repercussions on quality of life (QoL). This study is a pioneering Randomized Controlled Trial (RCT) in Portugal, which seeks to study the impact of a hedonic aroma during chemotherapy on women with breast cancer (3, 6 and 9 weeks, and 3 months after completion of chemotherapy). To this end, participants will be randomly assigned to one of the groups. The experimental group (EG) will be exposed to chemotherapy together with a hedonic aroma, while the control group (CG) will only be exposed to chemotherapy. Both groups will be assessed on psychological morbidity, illness perception, self-efficacy for coping, executive function, cortisol levels, side-effects, beliefs about chemotherapy and QoL.
The aim of this study is to assess the impact of a hedonic aroma on the clinical, emotional and neurocognitive variables that contribute to reducing the side effects of chemotherapy and promoting QoL in women with BC.
Detailed 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.
Investigators
Marta Alexandra Marques Pereira
Principal Investigator
University of Minho
Eligibility Criteria
Inclusion Criteria
- •women with BC in stages 0-2;
- •level 0-2 on the Zubrod scale,
- •without cognitive impairment,
- •adjuvant chemotherapy (AQ) treatment.
Exclusion Criteria
- •Severe mental disturbance;
- •olfactory impairment (≤6), evaluated before CT through the instrument smell diskettes and only in the EG participants
Outcomes
Primary Outcomes
Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ
Time Frame: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months
Assessment instruments: the European Organization for Research and Treatment of Cancer - Quality of Life (EORTC QLQ-C30) (Aaronson et al., 1993; Pais-Ribeiro, Pinto \& Santos, 2008). 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)
Anxiety and depression - The experimental group presented, in comparison to the control group, lower anxiety and depression
Time Frame: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months
Assessment instruments: Hospital Anxiety and Depression Scale (HADS, Pais-Ribeiro et al., 2007) comprising both anxiety and depression scales. Scores range between 0 and 42 (anxiety between 0 and 21 and depression the same), with higher results indicating higher levels of distress.
Secondary Outcomes
- Distress(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Working memory(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Saliva cortisol(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Subscales of the Quality of Life in Breast Cancer(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Illness Perceptions(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Self-efficacy for coping(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Cognitive Flexibility(Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months)
- Beliefs about chemotherapy(Changes from the 2nd cycle of chemotherapy (T1) (each cycle takes, on average, 2 hours with 3-week intervals between each cycle) until the date of 4th cycle of CT, assessed up to an average 1,5 months (T3))