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Completed

NCT Number: NCT03585218

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

António Fradão

Viana do Castelo, Estrada de Santa Luzia, 4904-858, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhalation of essential oils

Biological

Intervention "Inhalation of essential oils": From the T1 (2nd Cycle CT), 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 CT, 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.

Primary outcomes

  1. 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)

  2. 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

  1. Distress

    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: Emotions Thermometer (TE, Mitchell, Baker-Glenn, Granger, & Symonds, 2010; Teixeira et al., 2019) consisting of five analogue-visual scales, with four domains to identify emotional complications (distress, anxiety, depression, anger) and one outcome domain (need for help). In each thermometer de scores range between 0 and 10. A high result indicates emotional distress.

  2. Saliva cortisol

    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

    The collection of saliva for the evaluation of cortisol concentrations was performed using salivettes® (Starsedt). The procedure to assess salivary cortisol concentrations was implemented according to the protocol stipulated by IBL International (Cortisol Saliva ELISA, IBL International GMBH).

  3. Subscales of the Quality of Life in Breast Cancer

    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, Module for Breast Cancer (EORTC QLQ-BR23, Sprangers et al., 2006. In this study, only the breast symptoms (scores range between 4-16), body image (scores range between 4-16), sexual functioning (scores range between 2-8) and side effects (scores range between 7-28) subscales were used. High scores indicate higher body image, sexual functioning and breast symptoms.

  4. Illness Perceptions

    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: Illness Perception Questionnaire (IPQ-Brief, Broadbent, Petrie, Main, & Weinman, 2006; Figueiras et al., 2010). This instrument comprises 9 items that assess patients' cognitive and emotional representations of the disease. There is one item that is open-ended and asks the perceived causes of the disease (not used in the study). Scores range between 0 and 80. Higher scores indicate a more threatening illness perception.

  5. Self-efficacy for coping

    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: Cancer Behavior Inventory-Brief Version (CBI-B, Heitzmann et al., 2011). This instrument evaluates self-efficacy for coping in cancer patients through 12-item. Scores range between 12 and 108 and higher scores indicate more effective coping strategies.

  6. Working memory

    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: WAIS III Subtest - Digit Span (Wechsler, 2008). It evaluates patients' working memory in clinical practice consisting of two parts: The Digit Span Forward (scores range between 0-16 maximum) and Digit Span Backward (DSB) (scores range between 0-14 maximum). High scores indicate high immediate auditory memory and working memory.

  7. Cognitive Flexibility

    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: Trail Making Test (TMT, Partington & Leiter, 1949; Cavaco et al., 2013). This instrument is composed of part A, which evaluates attention, visual tracking and speed of graphomotor coordination and information processing; and Part B evaluates Part A functions and the ability to switch between a set of stimuli. Lower raw indices and higher adjusted scores correspond to better cognitive performance.

  8. Beliefs about chemotherapy

    Time frame: 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)

    Assessment instruments: Beliefs about chemotherapy (BMQ, Horne, Weinman, & Hankins, 1997; Pereira, Pedras, & Machado, 2013). This instrument is composed of 18 items and comprises two sections: BMQ - Specific and BMQ-General. In this study, only the specific section was used regarding chemotherapy. The BMQ - Specific section incorporates two sub-scales of five items each: Specific Needs and Specific Concerns related to the dangers of dependence and toxicity and concerns regarding long-term side effects, respectively. The total on the Specific Needs Scale ranges from 5 to 25 and on the Specific Concerns Scale from 5 to 25. Higher scores in each subscale indicate stronger beliefs regarding the need of treatment and regarding concerns towards the treatment, respectively.

Other outcomes

  1. Sociodemographic and Clinical Data

    Time frame: Time Frame: before chemotherapy (CT) treatment

    Assessment instruments: This instrument was developed specifically for this study, and included 11 items to assess sociodemographic variables (age, marital status, education, and occupation) and clinical variables (type of surgery, disease stage, number of planned cycles, tumor grade, sentinel lymph node, molecular markers and take hormone therapy).

  2. ECOG Performance Status (Oken et al., 1982)

    Time frame: Time Frame: before CT for inclusion criteria

    The Zubrod scale evaluates patients' performance status, where 0 refers to fully functional and asymptomatic and 5 to dead. It was used for inclusion criteria (West & Jin, 2015).

  3. Smell Diskettes (Simmen, Briner & Hess, 1999).

    Time frame: Time Frame: before CT for inclusion criteria

    This test consists of eight reusable diskettes containing different odors. It is a test that aims to evaluate the olfactory function. According to the results, a score between 7 and 8 corresponds to a normal olfactory function and ≥6 presents a compromised olfactory function (as for example with a hyposmia or anosmia).

  4. Short Assessment of Health Literacy (SAHL, Lee et al., 2010; Apolinario et al., 2012).

    Time frame: Time Frame: before CT for inclusion criteria

    This instrument assesses the degree of health literacy through the recognition of medical words, associating them with other words of similar meaning. Higher scores indicate a higher level of health literacy. A cutoff point of <14 has been assumed to distinguish between adequate and inadequate literacy (Apolinario et al., 2012).

Sponsors and collaborators

Lead sponsor

University of Minho

Other

Collaborators

  • Foundation for Science and Technology, Portugal

Registry information

Official study title

Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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