Clinical trial NCT05956457 - References

Multiple Myeloma — PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma

Citation(s)

•   Banerjee R, Huang CY, Dunn L, Knoche J, Ryan C, Brassil K, Jackson L, Patel D, Lo M, Arora S, Wong SW, Wolf J, Martin Iii T, Dhruva A, Shah N
  Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study. JMIR Form Res. 2022 Mar 4;6(3):e33701. doi: 10.2196/33701.
•   Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D
  Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
•   Cocks K, Cohen D, Wisloff F, Sezer O, Lee S, Hippe E, Gimsing P, Turesson I, Hajek R, Smith A, Graham L, Phillips A, Stead M, Velikova G, Brown J; EORTC Quality of Life Group
  An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007 Jul;43(11):1670-8. doi: 10.1016/j.ejca.2007.04.022. Epub 2007 Jun 15.
•   Cormican O, Dowling M
  Managing relapsed myeloma: The views of patients, nurses and doctors. Eur J Oncol Nurs. 2016 Aug;23:51-8. doi: 10.1016/j.ejon.2016.04.003. Epub 2016 May 11.
•   de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D
  Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
•   Girault A, Ferrua M, Lalloue B, Sicotte C, Fourcade A, Yatim F, Hebert G, Di Palma M, Minvielle E
  Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients. Eur J Cancer. 2015 Mar;51(4):551-557. doi: 10.1016/j.ejca.2014.12.001. Epub 2015 Feb 4.
•   Hari P
  Recent advances in understanding multiple myeloma. Hematol Oncol Stem Cell Ther. 2017 Dec;10(4):267-271. doi: 10.1016/j.hemonc.2017.05.005. Epub 2017 Jun 13.
•   Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG
  Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
•   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.
•   Kelly M, Dowling M
  Patients' lived experience of myeloma. Nurs Stand. 2011 Mar 16-22;25(28):38-44. doi: 10.7748/ns2011.03.25.28.38.c8397.
•   Kent EE, Ambs A, Mitchell SA, Clauser SB, Smith AW, Hays RD
  Health-related quality of life in older adult survivors of selected cancers: data from the SEER-MHOS linkage. Cancer. 2015 Mar 1;121(5):758-65. doi: 10.1002/cncr.29119. Epub 2014 Nov 4.
•   LeBlanc MR, Hirschey R, Leak Bryant A, LeBlanc TW, Smith SK
  How are patient-reported outcomes and symptoms being measured in adults with relapsed/refractory multiple myeloma? A systematic review. Qual Life Res. 2020 Jun;29(6):1419-1431. doi: 10.1007/s11136-019-02392-6. Epub 2019 Dec 17.
•   Lee MK, Schalet BD, Cella D, Yost KJ, Dueck AC, Novotny PJ, Sloan JA
  Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Patient Rep Outcomes. 2020 Dec 10;4(1):106. doi: 10.1186/s41687-020-00271-0. Erratum In: J Patient Rep Outcomes. 2021 Feb 5;5(1):20. J Patient Rep Outcomes. 2023 Jul 10;7(1):66.
•   Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brahler E
  A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010 Apr;122(1-2):86-95. doi: 10.1016/j.jad.2009.06.019. Epub 2009 Jul 17.
•   Madduri D, Dhodapkar MV, Lonial S, Jagannath S, Cho HJ
  SOHO State of the Art Updates and Next Questions: T-Cell-Directed Immune Therapies for Multiple Myeloma: Chimeric Antigen Receptor-Modified T Cells and Bispecific T-Cell-Engaging Agents. Clin Lymphoma Myeloma Leuk. 2019 Sep;19(9):537-544. doi: 10.1016/j.clml.2019.08.002. Epub 2019 Aug 7.
•   Madore S, Kilbourn K, Valverde P, Borrayo E, Raich P
  Feasibility of a psychosocial and patient navigation intervention to improve access to treatment among underserved breast cancer patients. Support Care Cancer. 2014 Aug;22(8):2085-93. doi: 10.1007/s00520-014-2176-5. Epub 2014 Mar 18.
•   Maher K, de Vries K
  An exploration of the lived experiences of individuals with relapsed multiple myeloma. Eur J Cancer Care (Engl). 2011 Mar;20(2):267-75. doi: 10.1111/j.1365-2354.2010.01234.x. Epub 2010 Oct 18.
•   Mannheimer SB, Mukherjee R, Hirschhorn LR, Dougherty J, Celano SA, Ciccarone D, Graham KK, Mantell JE, Mundy LM, Eldred L, Botsko M, Finkelstein R
  The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy. AIDS Care. 2006 Oct;18(7):853-61. doi: 10.1080/09540120500465160.
•   Moreno L, Perez C, Zabaleta A, Manrique I, Alignani D, Ajona D, Blanco L, Lasa M, Maiso P, Rodriguez I, Garate S, Jelinek T, Segura V, Moreno C, Merino J, Rodriguez-Otero P, Panizo C, Prosper F, San-Miguel JF, Paiva B
  The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma. Clin Cancer Res. 2019 May 15;25(10):3176-3187. doi: 10.1158/1078-0432.CCR-18-1597. Epub 2019 Jan 28.
•   Nielsen LK, Jarden M, Andersen CL, Frederiksen H, Abildgaard N
  A systematic review of health-related quality of life in longitudinal studies of myeloma patients. Eur J Haematol. 2017 Jul;99(1):3-17. doi: 10.1111/ejh.12882. Epub 2017 Apr 25.
•   Osoba D, Aaronson N, Zee B, Sprangers M, te Velde A
  Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study Group on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group. Qual Life Res. 1997 Mar;6(2):103-8. doi: 10.1023/a:1026429831234.
•   Proskorovsky I, Lewis P, Williams CD, Jordan K, Kyriakou C, Ishak J, Davies FE
  Mapping EORTC QLQ-C30 and QLQ-MY20 to EQ-5D in patients with multiple myeloma. Health Qual Life Outcomes. 2014 Mar 11;12:35. doi: 10.1186/1477-7525-12-35.
•   Ramsenthaler C, Kane P, Gao W, Siegert RJ, Edmonds PM, Schey SA, Higginson IJ
  Prevalence of symptoms in patients with multiple myeloma: a systematic review and meta-analysis. Eur J Haematol. 2016 Nov;97(5):416-429. doi: 10.1111/ejh.12790. Epub 2016 Sep 6.
•   Rothwell PM
  External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8.
•   Schumacher A, Kessler T, Buchner T, Wewers D, van de Loo J
  Quality of life in adult patients with acute myeloid leukemia receiving intensive and prolonged chemotherapy -- a longitudinal study. Leukemia. 1998 Apr;12(4):586-92. doi: 10.1038/sj.leu.2400977.
•   Schumacher A, Wewers D, Heinecke A, Sauerland C, Koch OM, van de Loo J, Buchner T, Berdel WE
  Fatigue as an important aspect of quality of life in patients with acute myeloid leukemia. Leuk Res. 2002 Apr;26(4):355-62. doi: 10.1016/s0145-2126(01)00145-x.
•   Siegel RL, Miller KD, Fuchs HE, Jemal A
  Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359.
•   Ventura F, Ohlen J, Koinberg I
  An integrative review of supportive e-health programs in cancer care. Eur J Oncol Nurs. 2013 Aug;17(4):498-507. doi: 10.1016/j.ejon.2012.10.007. Epub 2012 Nov 15.
•   Zaleta AK, Miller MF, Olson JS, Yuen EYN, LeBlanc TW, Cole CE, McManus S, Buzaglo JS
  Symptom Burden, Perceived Control, and Quality of Life Among Patients Living With Multiple Myeloma. J Natl Compr Canc Netw. 2020 Aug;18(8):1087-1095. doi: 10.6004/jnccn.2020.7561.
•   Zhang T, Wang S, Lin T, Xie J, Zhao L, Liang Z, Li Y, Jiang J
  Systematic review and meta-analysis of the efficacy and safety of novel monoclonal antibodies for treatment of relapsed/refractory multiple myeloma. Oncotarget. 2017 May 16;8(20):34001-34017. doi: 10.18632/oncotarget.16987.

Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma

Details for clinical trial NCT05956457