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

NCT03585218 | Completed

• 1 other identifier: 175519021995
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Quality of Life; Breast Cancer; Essentials Oils; Adjuvant Chemotherapy; Salivary cortisol; Neuropsychophysiology

Outcome Measures

Primary Outcomes (2)

• Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ

  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)

  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

• Anxiety and depression - The experimental group presented, in comparison to the control group, lower anxiety and depression

  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.

  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

Secondary Outcomes (8)

• 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

• 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

Other Outcomes (4)

• Sociodemographic and Clinical Data

  Time Frame: before chemotherapy (CT) treatment

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

  Time Frame: before CT for inclusion criteria

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

  Time Frame: before CT for inclusion criteria

Study Arms (2)

Experimental Group

EXPERIMENTAL

The Experimental Group participants will be submitted to the inhalation of the hedonic aroma during the chemotherapeutic treatment, this being the intervention of the study.The control group is not subject to intervention.

Biological: Inhalation of essential oils

Control Group

NO INTERVENTION

The control group is not subject to intervention.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with BC in stages 0-2;
• level 0-2 on the Zubrod scale,
• without cognitive impairment,
• adjuvant chemotherapy (AQ) treatment.

You may not qualify if:

• Severe mental disturbance;
• olfactory impairment (≤6), evaluated before CT through the instrument smell diskettes and only in the EG participants

Sponsors & Collaborators

• University of Minho: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

António Fradão

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

Location

Related Publications (23)

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Apolinario D, Braga Rde C, Magaldi RM, Busse AL, Campora F, Brucki S, Lee SY. Short Assessment of Health Literacy for Portuguese-speaking Adults. Rev Saude Publica. 2012 Aug;46(4):702-11. doi: 10.1590/s0034-89102012005000047. Epub 2012 Jul 10.

  PMID: 22782124 BACKGROUND

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

  PMID: 16731240 BACKGROUND

• Cavaco S, Goncalves A, Pinto C, Almeida E, Gomes F, Moreira I, Fernandes J, Teixeira-Pinto A. Trail Making Test: regression-based norms for the Portuguese population. Arch Clin Neuropsychol. 2013 Mar;28(2):189-98. doi: 10.1093/arclin/acs115. Epub 2013 Jan 7.

  PMID: 23299183 BACKGROUND

• Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.

  PMID: 20204931 BACKGROUND

• Heitzmann CA, Merluzzi TV, Jean-Pierre P, Roscoe JA, Kirsh KL, Passik SD. Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B). Psychooncology. 2011 Mar;20(3):302-12. doi: 10.1002/pon.1735.

  PMID: 20878830 BACKGROUND

• Lee SY, Stucky BD, Lee JY, Rozier RG, Bender DE. Short Assessment of Health Literacy-Spanish and English: a comparable test of health literacy for Spanish and English speakers. Health Serv Res. 2010 Aug;45(4):1105-20. doi: 10.1111/j.1475-6773.2010.01119.x. Epub 2010 May 24.

  PMID: 20500222 BACKGROUND

• Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 2010 Feb;19(2):125-33. doi: 10.1002/pon.1523.

  PMID: 19296462 BACKGROUND

• Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010 May;25(5):1388-93. doi: 10.1093/ndt/gfp732. Epub 2010 Jan 12.

  PMID: 20067907 BACKGROUND

• Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and health. 1999; 14(1): 1-24.

  BACKGROUND

• Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

  PMID: 7165009 BACKGROUND

• Pais-Ribeiro JL, Pinto C, Santos C. Validation study of the Portuguese version of the QLC-C30-V. 3. Psicologia, Saúde & Doenças. (2008; 9(1): 89-102.

  BACKGROUND

• Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.

  PMID: 17365902 BACKGROUND

• Partington JE, Leiter RG. Partington's pathway test. Psychological Service Center Bulletin. 1949; 9-20.

  BACKGROUND

• Schneider R. There Is Something in the Air: Testing the Efficacy of a new Olfactory Stress Relief Method (AromaStick(R)). Stress Health. 2016 Oct;32(4):411-426. doi: 10.1002/smi.2636. Epub 2015 Mar 18.

  PMID: 25787105 BACKGROUND

• Simmen D, Briner HR, Hess K. [Screening of olfaction with smell diskettes]. Laryngorhinootologie. 1999 Mar;78(3):125-30. doi: 10.1055/s-2007-996844. German.

  PMID: 10226979 BACKGROUND

• Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

  PMID: 8874337 BACKGROUND

• Teixeira RJ, Machado JC, Faria S, Remondes-Costa S, Brandao T, Branco M, Moreira S, Pereira MG. Brief emotional screening in oncology: Specificity and sensitivity of the emotion thermometers in the Portuguese cancer population. Palliat Support Care. 2020 Feb;18(1):39-46. doi: 10.1017/S1478951519000208.

  PMID: 31164179 BACKGROUND

• Wechsler D. Escala de Inteligência de Wechsler para Adultos-Terceira Edição [Wechsler Adult Intelligence Scale-Third Edition] (WAIS-III). Lisboa: Cegoc. 2008

  BACKGROUND

• West HJ, Jin JO. JAMA Oncology Patient Page. Performance Status in Patients With Cancer. JAMA Oncol. 2015 Oct;1(7):998. doi: 10.1001/jamaoncol.2015.3113. No abstract available.

  PMID: 26335750 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Pereira MG, Pedras S, Machado JC. Validation of the questionnaire of beliefs towards medicines in type 2 diabetic patients. Psicologia: Teoria e Pesquisa. 2013; 29: 229-236.

  BACKGROUND

• Pereira M, Moreira CS, Izdebski P, Dias ACP, Nogueira-Silva C, Pereira MG. How Does Hedonic Aroma Impact Long-Term Anxiety, Depression, and Quality of Life in Women with Breast Cancer? A Cross-Lagged Panel Model Analysis. Int J Environ Res Public Health. 2022 Jul 28;19(15):9260. doi: 10.3390/ijerph19159260.

  PMID: 35954612 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marta Pereira, Master

  University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: July 12, 2018
• Study Start: March 6, 2017
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)