Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03585218
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2018-05-28
Brief Title:
Women With Breast Cancer Undergoing Chemotherapy Implications in Quality of Life
Sponsor:
University of Minho
Organization:
University of Minho
Study Overview
Official Title:
Clinical Emotional Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy Implications in Quality of Life
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg EORCT QLQ-C30 with a population standard deviation of 1543 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None