Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

Summary

In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.

Timeline

Start

2017-07-24

Primary completion

2021-12-07

Completion

2021-12-07

Publications

• Background Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.
• Background Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
• Background Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002 May;11(3):207-21. doi: 10.1023/a:1015276414526.
• Background Cobos B, Haskard-Zolnierek K, Howard K. White coat hypertension: improving the patient-health care practitioner relationship. Psychol Res Behav Manag. 2015 May 2;8:133-41. doi: 10.2147/PRBM.S61192. eCollection 2015.
• Background Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.
• Background de Rond ME, de Wit R, van Dam FS, Muller MJ. A pain monitoring program for nurses: effects on communication, assessment and documentation of patients' pain. J Pain Symptom Manage. 2000 Dec;20(6):424-39. doi: 10.1016/s0885-3924(00)00209-8.
• Background Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
• Background Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027.
• Background Dorand RD, Nthale J, Myers JT, Barkauskas DS, Avril S, Chirieleison SM, Pareek TK, Abbott DW, Stearns DS, Letterio JJ, Huang AY, Petrosiute A. Cdk5 disruption attenuates tumor PD-L1 expression and promotes antitumor immunity. Science. 2016 Jul 22;353(6297):399-403. doi: 10.1126/science.aae0477. Epub 2016 Jul 21.
• Background Eton DT, Cella D, Yost KJ, Yount SE, Peterman AH, Neuberg DS, Sledge GW, Wood WC. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004 Sep;57(9):898-910. doi: 10.1016/j.jclinepi.2004.01.012.
• Background Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.
• Background Finn RS, Martin M, Rugo HS, Jones SE, Im SA, Gelmon KA, Harbeck N, Lipatov ON, Walshe JM, Moulder SL, Gauthier ER, Lu D, Randolph S, Diéras V, Slamon DJ. PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in post-menopausal women with ER+/HER2- advanced breast cancer (ABC). J Clin Oncol 34, 2016 (suppl; abstr 507)
• Background Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
• Background Harbeck, N., R. Wuerstlein and T. Schinkoethe (2015).
• Background U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79.
• Background Kalbfleisch, J.D., Prentice, R. L. (2002). "The statistical analysis of failure time data" (2nd Ed.) John Wily & Sons, p. 224
• Background Miller RD, Walsh TD. Psychosocial aspects of palliative care in advanced cancer. J Pain Symptom Manage. 1991 Jan;6(1):24-9. doi: 10.1016/0885-3924(91)90068-f.
• Background Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8.
• Background Politi MC, Clark MA, Ombao H, Dizon D, Elwyn G. Communicating uncertainty can lead to less decision satisfaction: a necessary cost of involving patients in shared decision making? Health Expect. 2011 Mar;14(1):84-91. doi: 10.1111/j.1369-7625.2010.00626.x. Epub 2010 Sep 23.
• Background Rosenbloom DI, Hill AL, Rabi SA, Siliciano RF, Nowak MA. Antiretroviral dynamics determines HIV evolution and predicts therapy outcome. Nat Med. 2012 Sep;18(9):1378-85. doi: 10.1038/nm.2892.
• Background Schoenfeld, D. A., Tsiatis, A. A. (1987)."A modified log rank test for highly stratified data." Biometrika, 167-175
• Background Townsend A, Leese J, Adam P, McDonald M, Li LC, Kerr S, Backman CL. eHealth, Participatory Medicine, and Ethical Care: A Focus Group Study of Patients' and Health Care Providers' Use of Health-Related Internet Information. J Med Internet Res. 2015 Jun 22;17(6):e155. doi: 10.2196/jmir.3792.
• Background Turner NC, Ro J, Andre F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, Giorgetti C, Randolph S, Koehler M, Cristofanilli M; PALOMA3 Study Group. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Jul 16;373(3):209-19. doi: 10.1056/NEJMoa1505270. Epub 2015 Jun 1.
• Background Vanden Bush TJ, Bishop GA. CDK-mediated regulation of cell functions via c-Jun phosphorylation and AP-1 activation. PLoS One. 2011 Apr 29;6(4):e19468. doi: 10.1371/journal.pone.0019468.
• Background Wells AD, Morawski PA. New roles for cyclin-dependent kinases in T cell biology: linking cell division and differentiation. Nat Rev Immunol. 2014 Apr;14(4):261-70. doi: 10.1038/nri3625. Epub 2014 Mar 7.
• Background Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval Health Prof. 2005 Jun;28(2):172-91. doi: 10.1177/0163278705275340.
• Harbeck N, Fasching PA, Wuerstlein R, Degenhardt T, Luftner D, Kates RE, Schumacher J, Rath P, Hoffmann O, Lorenz R, Decker T, Reinisch M, Gohler T, Staib P, Gluz O, Schinkothe T, Schmidt M; AGO-B WSG PreCycle investigators (see Appendix 1). Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2- metastatic breast cancer patients receiving palbociclib and endocrine therapy: primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial. Ann Oncol. 2023 Aug;34(8):660-669. doi: 10.1016/j.annonc.2023.05.003. Epub 2023 May 16.

Drugs

Indications