Abstract
Background
Patients’ experience of symptoms and associated treatment is an increasingly important consideration in both regulatory and health technology assessments, and can inform treatment decisions.
Objective
This study aimed to gain insight directly from patients with advanced breast cancer about which symptoms and treatment side effects are important to them.
Methods
Women with locally advanced or metastatic breast cancer were interviewed individually by trained interviewers, using a semi-structured interview guide. Verbatim transcripts were analyzed qualitatively, including whether symptoms were mentioned spontaneously (indicating their importance to patients) or only when questioned directly.
Results
Sixteen women (aged 38–74 years) participated. The most commonly reported symptom aspects were: pain (16/16 [all reported spontaneously]); feeling tired/fatigued (15/16 [12 spontaneously]); changes in weight (15/16 [2 spontaneously]); hair loss (15/16 [5 spontaneously]); changes in appetite (11/16 [8 spontaneously]); nausea (9/16 [all spontaneously]). Pain was attributed mostly to the disease or to its treatment. Tiredness, changes in weight/appetite, and hair loss were attributed mostly to the treatment. All women (14 spontaneously) reported that the cancer affected their emotional well-being and their ability to perform daily activities.
Conclusions
Further qualitative research is needed to understand how patients distinguish cancer-related symptoms from treatment-related side effects, to gain insight into which patient experiences should be measured and how best to measure them.
Similar content being viewed by others
References
Harris SR, Templeton E. Who’s listening? Experiences of women with breast cancer in communicating with physicians. Breast J. 2001;7:444–9.
Ganz PA. Psychological and social aspects of breast cancer. Oncology (Williston Park). 2008;22:642–6.
EMA. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf. Accessed 12 July 2016.
EMA. Reflection paper on the use of patient reported outcome (PRO) measures in oncology studies. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf. Accessed 12 July 2016.
FDA. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009 [final guidance document]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed 12 July 2016.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, 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;3(85):365–76.
Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, et al. 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;14:2756–68.
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11:570–9.
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997;15:974–86.
Turner-Bowker DM, Hao Y, Foley C, Galipeau N, Mazar I, Krohe M, et al. The use of patient-reported outcomes in advanced breast cancer clinical trials: a review of the published literature. Curr Med Res Opin. 2016;22:1–37.
Ong WL, Schouwenburg MG, van Bommel AC, Stowell C, Allison KH, Benn KE, et al. A standard set of value-based patient-centered outcomes for breast cancer: the International Consortium for Health Outcomes Measurement (ICHOM) initiative. JAMA Oncol. 2016. Epub 29 Dec 2016. doi:10.1001/jamaoncol.2016.4851.
Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, et al. Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. Lancet Oncol. 2016;17:e294–304.
Luckett T, King MT, Butow PN, Oguchi M, Rankin N, Price MA, et al. Choosing between the EORTC QLQ-C30 and FACT-G for measuring health-related quality of life in cancer clinical research: issues, evidence and recommendations. Ann Oncol. 2011;22:2179–90.
Mosher CE, Daily S, Tometich D, Matthias MS, Outcalt SD, Hirsh A, et al. Factors underlying metastatic breast cancer patients’ perceptions of symptom importance: a qualitative analysis. Eur J Cancer Care. 2016;27:12540.
Trusson D, Pilnick A. The role of hair loss in cancer identity: perceptions of chemotherapy-induced alopecia among women treated for early-stage breast cancer or ductal carcinoma in situ. Cancer Nurs. 2017;40:E9–16.
Lo-Fo-Wong DN, de Haes HC, Aaronson NK, van Abbema DL, den Boer MD, van Hezewijk M, et al. Predictors of enduring clinical distress in women with breast cancer. Breast Cancer Res Treat. 2016;158:563–72.
Kanatas A, Lowe D, Velikova G, Roe B, Horgan K, Shaw RJ, et al. Issues patients would like to discuss at their review consultation in breast cancer clinics—a cross-sectional survey. Tumori. 2014;100:568–79.
daCosta DiBonaventura M, Copher R, Basurto E, Faria C, Lorenzo R. Patient preferences and treatment adherence among women diagnosed with metastatic breast cancer. Am Health Drug Benefits. 2014;7:386–96.
Garcia SF, Rosenbloom SK, Beaumont JL, Merkel D, Von Roenn JH, Rao D, et al. Priority symptoms in advanced breast cancer: development and initial validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16). Value Health. 2012;15:183–90.
Montemurro F, Mittica G, Cagnazzo C, Longo V, Berchialla P, Solinas G, et al. Self-evaluation of adjuvant chemotherapy-related adverse effects by patients with breast cancer. JAMA Oncol. 2016;2:445–52.
Lewis S, Yee J, Kilbreath S, Willis K. A qualitative study of women’s experiences of healthcare, treatment and support for metastatic breast cancer. Breast. 2015;24:242–7.
Vilhauer RP. A qualitative study of the experiences of women with metastatic breast cancer. Palliat Support Care. 2008;6:249–58.
Bredart A, Marrel A, Abetz-Webb L, Lasch K, Acquadro C. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience. Health Qual Life Outcomes. 2014;12:15.
Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new PRO instrument. Value Health. 2011;14:967–77.
Krigel S, Myers J, Befort C, Krebill H, Klemp J. ‘Cancer changes everything!’ Exploring the lived experiences of women with metastatic breast cancer. Int J Palliat Nurs. 2014;20:334–42.
Karlin S. Breast cancer patients, FDA disagree on value of time-to-metastasis endpoints. The Pink Sheet. 2015 Apr 13;Article #00150413002.
van Londen GJ, Donovan HS, Beckjord EB, Cardy AL, Bovbjerg DH, Davidson NE, et al. Perspectives of postmenopausal breast cancer survivors on adjuvant endocrine therapy-related symptoms. Oncol Nurs Forum. 2014;41:660–8.
Acknowledgements
This study was funded by AstraZeneca Gothenburg, Mölndal, Sweden. Writing support was provided by Dr Anja Becher of Oxford PharmaGenesis, Oxford, UK and was funded by AstraZeneca Gothenburg, Mölndal, Sweden. The authors thank Adelphi Values for conducting the interviews.
Author information
Authors and Affiliations
Contributions
Anna Niklasson contributed to the study design, data analysis, interpretation of results, and writing and reporting. Jean Paty contributed to the study design, interpretation of results, and writing and reporting. Anna Rydén contributed to study design, data analysis, interpretation of results, and writing and reporting. All authors approved the manuscript.
Corresponding author
Ethics declarations
Conflict of interest
Anna Niklasson and Anna Rydén are employees of AstraZeneca Gothenburg, Mölndal, Sweden and have AstraZeneca stock/stock options. Jean Paty is an employee of Quintiles, New York, NY, USA, which has received contracts to perform consulting services to AstraZeneca.
Ethical standards
The study was performed in accordance with the principles stated in the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements. The study was overseen and approved by a centralized ethics committee (Quorum Group Institutional Review Board). Written informed consent was obtained from all participants before the start of the study. All individual identifying information was removed from summary transcripts, coded data, and reports generated from the interviews.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Niklasson, A., Paty, J. & Rydén, A. Talking About Breast Cancer: Which Symptoms and Treatment Side Effects are Important to Patients with Advanced Disease?. Patient 10, 719–727 (2017). https://doi.org/10.1007/s40271-017-0242-z
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40271-017-0242-z