Skip to main content

Advertisement

SpringerLink
Log in

Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial

  • Clinical trial
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1–111.7) compared to the usual care group (102.2; 98.5–105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6–8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M (2012) How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther 11(3):187–203

    Article  PubMed  Google Scholar 

  2. Molassiotis A, Fernadez-Ortega P, Pud D, Ozden G, Scott JA, Panteli V, Margulies A, Browall M, Magri M, Selvekerova S, Madsen E, Milovics L, Bruyns I, Gudmundsdottir G, Hummerston S, Ahmad AM, Platin N, Kearney N, Patiraki E (2005) Use of complementary and alternative medicine in cancer patients: a European survey. Ann Oncol 16(4):655–663

    Article  CAS  PubMed  Google Scholar 

  3. Kang E, Yang EJ, Kim SM, Chung IY, Han SA, Ku DH, Nam SJ, Yang JH, Kim SW (2012) Complementary and alternative medicine use and assessment of quality of life in Korean breast cancer patients: a descriptive study. Support Care Cancer 20(3):461–473

    Article  PubMed  Google Scholar 

  4. Morris KT, Johnson N, Homer L, Walts D (2000) A comparison of complementary therapy use between breast cancer patients and patients with other primary tumor sites. Am J Surg 179(5):407–411

    Article  CAS  PubMed  Google Scholar 

  5. Boon HS, Olatunde F, Zick SM (2007) Trends in complementary/alternative medicine use by breast cancer survivors: comparing survey data from 1998 and 2005. BMC Womens Health 7:4

    Article  PubMed Central  PubMed  Google Scholar 

  6. McLay JS, Stewart D, George J, Rore C, Heys SD (2012) Complementary and alternative medicines use by Scottish women with breast cancer. What, why and the potential for drug interactions? Eur J Clin Pharmacol 68(5):811–819

    Article  CAS  PubMed  Google Scholar 

  7. Sewitch MJ, Yaffe M, Maisonneuve J, Prchal J, Ciampi A (2011) Use of complementary and alternative medicine by cancer patients at a Montreal hospital. Integr Cancer Ther 10(4):305–311

    Article  PubMed  Google Scholar 

  8. von Gruenigen VE, Frasure HE, Jenison EL, Hopkins MP, Gil KM (2006) Longitudinal assessment of quality of life and lifestyle in newly diagnosed ovarian cancer patients: the roles of surgery and chemotherapy. Gynecol Oncol 103(1):120–126

    Article  Google Scholar 

  9. Navo MA, Phan J, Vaughan C, Palmer JL, Michaud L, Jones KL, Bodurka DC, Basen-Engquist K, Hortobagyi GN, Kavanagh JJ, Smith JA (2004) An assessment of the utilization of complementary and alternative medication in women with gynecologic or breast malignancies. J Clin Oncol 22(4):671–677

    Article  PubMed  Google Scholar 

  10. Walker LG, Anderson J (1999) Testing complementary and alternative therapies within a research protocol. Eur J Cancer 35(11):1614–1618

    Article  CAS  PubMed  Google Scholar 

  11. Balneaves LG, Bottorff JL, Hislop TG, Herbert C (2006) Levels of commitment: exploring complementary therapy use by women with breast cancer. J Altern Complement Med 12(5):459–466

    Article  PubMed  Google Scholar 

  12. Shumay DM, Maskarinec G, Gotay CC, Heiby EM, Kakai H (2002) Determinants of the degree of complementary and alternative medicine use among patients with cancer. J Altern Complement Med 8(5):661–671

    Article  PubMed  Google Scholar 

  13. Brouwers MC, Thabane L, Moher D, Straus SE (2012) Comparative effectiveness research paradigm: implications for systematic reviews and clinical practice guidelines. J Clin Oncol 30(34):4202–4207

    Article  PubMed  Google Scholar 

  14. Mullins CD, Montgomery R, Tunis S (2010) Uncertainty in assessing value of oncology treatments. Oncologist 15(Suppl 1):58–64. doi:10.1634/theoncologist.:58-64

    Article  PubMed  Google Scholar 

  15. Institute of Medicine (2009) Advising the nation. Improving health. The National Academies Press, Washington D.C

    Google Scholar 

  16. Iglehart JK (2009) Prioritizing comparative-effectiveness research—IOM recommendations. N Engl J Med 361(4):325–328

    Article  CAS  PubMed  Google Scholar 

  17. Tunis SR, Benner J, McClellan M (2010) Comparative effectiveness research: policy context, methods development and research infrastructure. Stat Med 29(19):1963–1976

    Article  PubMed  Google Scholar 

  18. Tunis SR, Stryer DB, Clancy CM (2003) Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 290(12):1624–1632

    Article  CAS  PubMed  Google Scholar 

  19. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390

    Article  PubMed  Google Scholar 

  20. Chalkidou K, Tunis S, Whicher D, Fowler R, Zwarenstein M (2012) The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research. Clin Trials 9(4):436–446

    Article  PubMed  Google Scholar 

  21. Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G (1997) Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 15(3):974–986

    CAS  PubMed  Google Scholar 

  22. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11(3):570–579

    CAS  PubMed  Google Scholar 

  23. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E (1997) Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 13(2):63–74

    Article  CAS  PubMed  Google Scholar 

  24. Ware JE Jr (1976) SF-36 health survey update. Spine 25(24):3130–3139

    Article  Google Scholar 

  25. National Cancer Institute (2014) NCI Term Browser. Available at: http://nciterms.nci.nih.gov/ncitbrowser/pages/vocabulary.jsf?dictionary=Common%20Terminology%20Criteria%20for%20Adverse%20Events&version=4.03#. Retrieved Dec 2014

  26. Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, Wenzel K, Chauhan C, Eppard W, Frank ES, Lipscomb J, Raymond SA, Spencer M, Tunis S (2012) Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol 30(34):4249–4255

    Article  PubMed  Google Scholar 

  27. Crew KD, Capodice JL, Greenlee H, Brafman L, Fuentes D, Awad D, Yann TW, Hershman DL (2010) Randomized, blinded, sham-controlled trial of acupuncture for the management of aromatase inhibitor-associated joint symptoms in women with early-stage breast cancer. J Clin Oncol 28(7):1154–1160

    Article  CAS  PubMed  Google Scholar 

  28. Mao JJ, Xie SX, Farrar JT, Stricker CT, Bowman MA, Bruner D, DeMichele A (2014) A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. Eur J Cancer 50(2):267–276

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  29. Bao T, Cai L, Snyder C, Betts K, Tarpinian K, Gould J, Jeter S, Medeiros M, Chumsri S, Bardia A, Tan M, Singh H, Tkaczuk KH, Stearns V (2014) Patient-reported outcomes in women with breast cancer enrolled in a dual-center, double-blind, randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms. Cancer 120(3):381–389

    Article  PubMed  Google Scholar 

  30. Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A (2012) Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol 30(36):4470–4476

    Article  PubMed  Google Scholar 

  31. Smith C, Carmady B, Thornton C, Perz J, Ussher JM (2013) The effect of acupuncture on post-cancer fatigue and well-being for women recovering from breast cancer: a pilot randomised controlled trial. Acupunct Med 31(1):9–15

    Article  PubMed  Google Scholar 

  32. Linde K, Niemann K, Schneider A, Meissner K (2010) How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials. BMC Med 8:75

    Article  PubMed Central  PubMed  Google Scholar 

  33. Weissman JS, Schneider EC, Weingart SN, Epstein AM, David-Kasdan J, Feibelmann S, Annas CL, Ridley N, Kirle L, Gatsonis C (2008) Comparing patient-reported hospital adverse events with medical record review: do patients know something that hospitals do not? Ann Intern Med 149(2):100–108

    Article  PubMed  Google Scholar 

  34. Bower JE, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Greendale G (2012) Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial. Cancer 118(15):3766–3775

    Article  PubMed Central  PubMed  Google Scholar 

  35. Levine EG, Eckhardt J, Targ E (2005) Change in post-traumatic stress symptoms following psychosocial treatment for breast cancer. Psychooncology 14(8):618–635

    Article  PubMed  Google Scholar 

  36. Targ EF, Levine EG (2002) The efficacy of a mind-body-spirit group for women with breast cancer: a randomized controlled trial. Gen Hosp Psychiatry 24(4):238–248

    Article  PubMed  Google Scholar 

  37. Saquib J, Madlensky L, Kealey S, Saquib N, Natarajan L, Newman VA, Patterson RE, Pierce JP (2011) Classification of CAM use and its correlates in patients with early-stage breast cancer. Integr. Cancer Ther 10(2):138–147

    Article  PubMed Central  PubMed  Google Scholar 

  38. Beatty LJ, Adams J, Sibbritt D, Wade TD (2012) Evaluating the impact of cancer on complementary and alternative medicine use, distress and health related QoL among Australian women: a prospective longitudinal investigation. Complement Ther Med 20(1–2):61–69

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

We thank Dr. Claudio Graiff who participated in the advisory board and Dr. Angelina Bockelbrink for her work in preparing this study. Furthermore, we like to thank Dr. Markus Horneber for his helpful comments on the study protocol and Sylvia Binting for her support in categorizing the adverse event.

Funding information

This study was funded by the Federal State Government Trentino-Alto Adige (decision 37/2009).

Conflict of interest

Oskar Ausserer received remuneration from the Südtiroler Sanitätsbetrieb.

Author information

Authors and Affiliations

  1. Institute for Complementary and Integrative Medicine, University Hospital Zurich and University Zurich, Sonneggstr. 6, 8091, Zurich, Switzerland

    Claudia M. Witt

  2. Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, 10098, Berlin, Germany

    Claudia M. Witt, Katja Icke, Stephanie Roll & Lena Schützler

  3. Department of Complementary Medicine, Franz Tappeiner Hospital Merano, Rossini-Str. 5, 39012, Merano, Italy

    Oskar Außerer & Christian Thuile

  4. Department of Medical Oncology, Hospital Bolzano , Lorenz Böhler Str. 5, 39199, Bolzano, Italy

    Susanne Baier

  5. Department of Gynaecology and Obstetrics, Franz Tappeiner Hospital Merano, Rossini-Str. 5, 39012, Merano, Italy

    Herbert Heidegger

  6. Südtiroler Sanitätsbetrieb, Bolzano, Italy

    Oswald Mayr

  7. Haemato-Oncological Day Hospital, Franz Tappeiner Hospital Merano, Rossini-Str. 5, 39012, Merano, Italy

    Manfred Mitterer & Gilbert Spizzo

  8. Department of Gynaecology and Obstetrics, Bressanone Hospital, Dantestr. 51, 39042, Bressanone, Italy

    Arthur Scherer

  9. Department of Radiology, Franz Tappeiner Hospital Merano, Rossini-Str. 5, 39012, Merano, Italy

    Anton Wieser

Authors
  1. Claudia M. Witt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Oskar Außerer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Susanne Baier
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Herbert Heidegger
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Katja Icke
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Oswald Mayr
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Manfred Mitterer
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Stephanie Roll
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Gilbert Spizzo
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Arthur Scherer
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Christian Thuile
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Anton Wieser
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Lena Schützler
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Claudia M. Witt.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Witt, C.M., Außerer, O., Baier, S. et al. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat 149, 449–460 (2015). https://doi.org/10.1007/s10549-014-3249-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10549-014-3249-3

Keywords

Search

Navigation