NCT05576545 — Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment · CancerIndex
Clinical trial · Interventional
Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment
This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
general routine care and the Breast Cancer Self-Care App
interventionNames
Device: The Breast Cancer Self-Care App
type
NO_INTERVENTION
label
general routine care
Primary outcomes (1)
measure
Self-efficacy
timeFrame
4 weeks
description
Use Strategies Used by People to Promote Health (SUPPH) measure self-care self-efficacy. The scale total of 29 items measure self-care self-efficacy. There are 3 sub subscales for each of the following: Stress Reduction (10 items, 5-50scores), Making Decisions (3 items, 3-15scores), Positive Attitude (16 items,16-80 scores). The range of total scores of the scale is 29-145. It shows that self-care self-efficacy increases as total points of the scale increase.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
20 Years
Maximum age
65 Years
Show eligibility criteria text
Inclusion Criteria:
* Consciousness clear, over 20 years old, can communicate in Mandarin and Taiwanese
* Diagnosed Breast Cancer I-III stage
* undergo first chemotherapy
* Have a smartphone
* Receiving treatment: EC/ EC+T/LC/LC+T E: (Epirubicin)、C: (Cyclophosphamide)、L: (Lipo-Dox)、T: (Taxotere)
Exclusion Criteria:
* DSM-V mentally ill
* IOS system smartphone
* over 65 years old
References
Publications (65)
BACKGROUNDAizpurua-Perez I, Perez-Tejada J. Resilience in women with breast cancer: A systematic review. Eur J Oncol Nurs. 2020 Dec;49:101854. doi: 10.1016/j.ejon.2020.101854. Epub 2020 Oct 10. PMID 33120216
BACKGROUNDAjčević, M., Dea, F. D., Barbieri, G., & Accardo, A. (2019). A mobile app for the self-management of type 1 diabetes as tool for preventing of exercise-associated glycemic imbalances. World Congress on Medical Physics and Biomedical Engineering 475-479. https://doi.org/10.1007/978-981-10-9035-6_88
BACKGROUNDAkin S, Can G, Durna Z, Aydiner A. The quality of life and self-efficacy of Turkish breast cancer patients undergoing chemotherapy. Eur J Oncol Nurs. 2008 Dec;12(5):449-56. doi: 10.1016/j.ejon.2008.07.006. Epub 2008 Oct 7. PMID 18842460
BACKGROUNDAkin S, Kas Guner C. Investigation of the relationship among fatigue, self-efficacy and quality of life during chemotherapy in patients with breast, lung or gastrointestinal cancer. Eur J Cancer Care (Engl). 2019 Jan;28(1):e12898. doi: 10.1111/ecc.12898. Epub 2018 Jul 24. PMID 30039883
BACKGROUNDAungst TD, Clauson KA, Misra S, Lewis TL, Husain I. How to identify, assess and utilise mobile medical applications in clinical practice. Int J Clin Pract. 2014 Feb;68(2):155-62. doi: 10.1111/ijcp.12375. PMID 24460614
BACKGROUNDAwan A, Esfahani K. Endocrine therapy for breast cancer in the primary care setting. Curr Oncol. 2018 Aug;25(4):285-291. doi: 10.3747/co.25.4139. Epub 2018 Aug 14. PMID 30111969
BACKGROUNDAyyoubzadeh SM, Shirkhoda M, R Niakan Kalhori S, Mohammadzadeh N, Zakerabasali S. A Smartphone Remote Monitoring App to Follow Up Colorectal Cancer Survivors: Requirement Analysis. JMIR Cancer. 2022 Jan 5;8(1):e18083. doi: 10.2196/18083. PMID 34989685
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
measure
Resilience
timeFrame
4 weeks
description
Use Resilience scale 14 items (RS-14) measure individual resilience. The scale with a total of 14 items measures resilience. The range of total scores of the scale is 14-98. It shows that resilience increases as total points of the scale increase.
BACKGROUNDBandura, A. (1982). Self-efficacy mechanism in human agency. American psychologist, 37(2), 122. https://doi.org/10.1037/0003-066X.37.2.122
BACKGROUNDBandura, A. (1986). The explanatory and predictive scope of self-efficacy theory. Journal of Social and Clinical Psychology, 4(3), 359-373. https://doi.org/10.1521/jscp.1986.4.3.359
BACKGROUNDBandura, A. (2010). Self-efficacy the corsini encyclopedia of psychology. John Wiley & Sons, 10, 1-3. https://doi.org/10.1002/9780470479216.corpsy0836
BACKGROUNDBandura, A., Freeman, W., & Lightsey, R. (1999). Self-efficacy: The exercise of control. 15-17. https://doi.org/10.1007/BF02352723
BACKGROUNDBaumel A, Torous J, Edan S, Kane JM. There is a non-evidence-based app for that: A systematic review and mixed methods analysis of depression- and anxiety-related apps that incorporate unrecognized techniques. J Affect Disord. 2020 Aug 1;273:410-421. doi: 10.1016/j.jad.2020.05.011. Epub 2020 May 11. PMID 32560936
BACKGROUNDBritton WB. Can mindfulness be too much of a good thing? The value of a middle way. Curr Opin Psychol. 2019 Aug;28:159-165. doi: 10.1016/j.copsyc.2018.12.011. Epub 2019 Jan 7. PMID 30708288
BACKGROUNDBuneviciene I, Mekary RA, Smith TR, Onnela JP, Bunevicius A. Can mHealth interventions improve quality of life of cancer patients? A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2021 Jan;157:103123. doi: 10.1016/j.critrevonc.2020.103123. Epub 2020 Oct 20. PMID 33190065
BACKGROUNDCai T, Huang Y, Zhang Y, Lu Z, Huang Q, Yuan C. Mobile health applications for the care of patients with breast cancer: A scoping review. Int J Nurs Sci. 2021 Aug 25;8(4):470-476. doi: 10.1016/j.ijnss.2021.07.003. eCollection 2021 Oct 10. PMID 34631997
BACKGROUNDChen YC, Huang HM, Kao CC, Sun CK, Chiang CY, Sun FK. The Psychological Process of Breast Cancer Patients Receiving Initial Chemotherapy: Rising From the Ashes. Cancer Nurs. 2016 Nov/Dec;39(6):E36-E44. doi: 10.1097/NCC.0000000000000331. PMID 26713500
BACKGROUNDChen HL, Liu K, You QS. Self-efficacy, cancer-related fatigue, and quality of life in patients with resected lung cancer. Eur J Cancer Care (Engl). 2018 Nov;27(6):e12934. doi: 10.1111/ecc.12934. Epub 2018 Sep 25. PMID 30252973
BACKGROUNDChirico A, Lucidi F, Merluzzi T, Alivernini F, Laurentiis M, Botti G, Giordano A. A meta-analytic review of the relationship of cancer coping self-efficacy with distress and quality of life. Oncotarget. 2017 May 30;8(22):36800-36811. doi: 10.18632/oncotarget.15758. PMID 28404938
BACKGROUNDChou YH, Chia-Rong Hsieh V, Chen X, Huang TY, Shieh SH. Unmet supportive care needs of survival patients with breast cancer in different cancer stages and treatment phases. Taiwan J Obstet Gynecol. 2020 Mar;59(2):231-236. doi: 10.1016/j.tjog.2020.01.010. PMID 32127143
BACKGROUNDCivilotti C, Acquadro Maran D, Santagata F, Varetto A, Stanizzo MR. The use of the Distress Thermometer and the Hospital Anxiety and Depression Scale for screening of anxiety and depression in Italian women newly diagnosed with breast cancer. Support Care Cancer. 2020 Oct;28(10):4997-5004. doi: 10.1007/s00520-020-05343-x. Epub 2020 Feb 8. PMID 32036468
BACKGROUNDConnor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. PMID 12964174
BACKGROUNDDaly RM, Gianoudis J, Hall T, Mundell NL, Maddison R. Feasibility, Usability, and Enjoyment of a Home-Based Exercise Program Delivered via an Exercise App for Musculoskeletal Health in Community-Dwelling Older Adults: Short-term Prospective Pilot Study. JMIR Mhealth Uhealth. 2021 Jan 13;9(1):e21094. doi: 10.2196/21094. PMID 33439147
BACKGROUNDDeng G. Integrative Medicine Therapies for Pain Management in Cancer Patients. Cancer J. 2019 Sep/Oct;25(5):343-348. doi: 10.1097/PPO.0000000000000399. PMID 31567462
BACKGROUNDEberle C, Lohnert M, Stichling S. Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review. JMIR Mhealth Uhealth. 2021 Feb 15;9(2):e23477. doi: 10.2196/23477. PMID 33587045
BACKGROUNDEller LS, Lev EL, Yuan C, Watkins AV. Describing Self-Care Self-Efficacy: Definition, Measurement, Outcomes, and Implications. Int J Nurs Knowl. 2018 Jan;29(1):38-48. doi: 10.1111/2047-3095.12143. Epub 2016 May 31. PMID 27245100
BACKGROUNDFanchiang YC, Yen YH, Chen SW. [Using Nursing Digital Technology to Reduce the Rates of Catheter-Associated and Non-Catheter-Associated Urinary Tract Infection]. Hu Li Za Zhi. 2019 Apr;66(2):77-84. doi: 10.6224/JN.201904_66(2).10. Chinese. PMID 30924517
BACKGROUNDFang SY, Wang YL, Lu WH, Lee KT, Kuo YL, Fetzer SJ. Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Patient Educ Couns. 2020 Mar;103(3):549-555. doi: 10.1016/j.pec.2019.09.012. Epub 2019 Sep 12. PMID 31558323
BACKGROUNDFini, I. A., Adib-Hajbaghery, M., & Khachian, A. (2011). The effect of health-promotion strategies education on self-care self-efficacy in patients with bone marrow transplantation. Iranian Journal of Critical Care Nursing, 4(3), 42-44. https://doi.org/10.1038/bmt.2008.113
BACKGROUNDFisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharm Nanotechnol. 2019;7(1):3-23. doi: 10.2174/2211738507666190122111224. PMID 30666921
BACKGROUNDGagnon MP, Ngangue P, Payne-Gagnon J, Desmartis M. m-Health adoption by healthcare professionals: a systematic review. J Am Med Inform Assoc. 2016 Jan;23(1):212-20. doi: 10.1093/jamia/ocv052. Epub 2015 Jun 15. PMID 26078410
BACKGROUNDGiuliano AE, Edge SB, Hortobagyi GN. Eighth Edition of the AJCC Cancer Staging Manual: Breast Cancer. Ann Surg Oncol. 2018 Jul;25(7):1783-1785. doi: 10.1245/s10434-018-6486-6. Epub 2018 Apr 18. No abstract available. PMID 29671136
BACKGROUNDGodfrey CM, Harrison MB, Lysaght R, Lamb M, Graham ID, Oakley P. Care of self - care by other - care of other: the meaning of self-care from research, practice, policy and industry perspectives. Int J Evid Based Healthc. 2011 Mar;9(1):3-24. doi: 10.1111/j.1744-1609.2010.00196.x. PMID 21332659
BACKGROUNDHabibullah G, Gul R, Cassum S, Elahi R. Experiences of the Breast Cancer Patients Undergoing Radiotherapy at a Public Hospital Peshawar Pakistan. Asia Pac J Oncol Nurs. 2018 Apr-Jun;5(2):184-194. doi: 10.4103/apjon.apjon_70_17. PMID 29607379
BACKGROUNDHarrison, R., Flood, D., & Duce, D. (2013). Usability of mobile applications: literature review and rationale for a new usability model. Journal of Interaction Science, 1(1), 1-16. https://doi.org/10.1186/2194-0827-1-1
BACKGROUNDHou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084. PMID 32130181
BACKGROUNDInan FS, Gunusen NP, Ustun B. Experiences of Newly Diagnosed Breast Cancer Patients in Turkey. J Transcult Nurs. 2016 May;27(3):262-9. doi: 10.1177/1043659614550488. Epub 2014 Sep 15. PMID 25225235
BACKGROUNDJongerius C, Russo S, Mazzocco K, Pravettoni G. Research-Tested Mobile Apps for Breast Cancer Care: Systematic Review. JMIR Mhealth Uhealth. 2019 Feb 11;7(2):e10930. doi: 10.2196/10930. PMID 30741644
BACKGROUNDKewan T, Alomari M, Khazaaleh S, Covut F, Olayan M. Hand-foot Syndrome Secondary to Low-dose Docetaxel in a Breast Cancer Patient. Cureus. 2019 Apr 6;11(4):e4400. doi: 10.7759/cureus.4400. PMID 31245190
BACKGROUNDKonaszewski, K., Kolemba, M., & Niesiobędzka, M. (2021). Resilience, sense of coherence and self-efficacy as predictors of stress coping style among university students. Current Psychology, 40(8), 4052-4062. https://doi.org/10.1007/s12144-019-00363-1
BACKGROUNDLatifi M, Alishan Karami N, Beiraghdar M, Maraki F, Allahbakhshian Farsani L. Impact of Health Information Prescription on Self-care of Women with Breast Cancer. Adv Biomed Res. 2018 Oct 31;7:139. doi: 10.4103/abr.abr_142_18. eCollection 2018. PMID 30505810
BACKGROUNDLee TY, Hsing SC, Li CC. An Improved Stress-Scale Specifically Designed to Measure Stress of Women with Newly Diagnosed Breast Cancer. Int J Environ Res Public Health. 2021 Feb 27;18(5):2346. doi: 10.3390/ijerph18052346. PMID 33673627
BACKGROUNDLin PJ, Fang SY, Kuo YL. Development and Usability Testing of a Decision Support App for Women Considering Breast Reconstruction Surgery. J Cancer Educ. 2021 Feb;36(1):160-167. doi: 10.1007/s13187-019-01612-4. PMID 31463810
BACKGROUNDLozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669. PMID 29588273
BACKGROUNDMeric-Bernstam F, Johnson AM, Dumbrava EEI, Raghav K, Balaji K, Bhatt M, Murthy RK, Rodon J, Piha-Paul SA. Advances in HER2-Targeted Therapy: Novel Agents and Opportunities Beyond Breast and Gastric Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2033-2041. doi: 10.1158/1078-0432.CCR-18-2275. Epub 2018 Nov 15. PMID 30442682
BACKGROUNDMessner, E.-M., Probst, T., O'Rourke, T., Stoyanov, S., & Baumeister, H. (2019). mHealth applications: potentials, limitations, current quality and future directions. In Digital Phenotyping and Mobile Sensing (pp. 235-248). Springer. https://doi.org/10.1007/978-3-030-31620-4_15
BACKGROUNDMoszeik, E. N., von Oertzen, T., & Renner, K.-H. (2020). Effectiveness of a short Yoga Nidra meditation on stress, sleep, and well-being in a large and diverse sample. Current Psychology, 1-15. https://link.springer.com/article/10.1007/s12144-020-01042-2
BACKGROUNDOmran S, Mcmillan S. Symptom Severity, Anxiety, Depression, Self- Efficacy and Quality of Life in Patients with Cancer. Asian Pac J Cancer Prev. 2018 Feb 26;19(2):365-374. doi: 10.22034/APJCP.2018.19.2.365. PMID 29479979
BACKGROUNDOsborn J, Ajakaiye A, Cooksley T, Subbe CP. Do mHealth applications improve clinical outcomes of patients with cancer? A critical appraisal of the peer-reviewed literature. Support Care Cancer. 2020 Mar;28(3):1469-1479. doi: 10.1007/s00520-019-04945-4. Epub 2019 Jul 4. PMID 31273501
BACKGROUNDPez M, Keller A, Welzel G, Abo-Madyan Y, Ehmann M, Tuschy B, Berlit S, Sutterlin M, Wenz F, Giordano FA, Sperk E. Long-term outcome after intraoperative radiotherapy as a boost in breast cancer. Strahlenther Onkol. 2020 Apr;196(4):349-355. doi: 10.1007/s00066-019-01525-7. Epub 2019 Oct 22. PMID 31641788
BACKGROUNDRiegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba. PMID 22739426
BACKGROUNDSheu, H.-B., Lent, R. W., Miller, M. J., Penn, L. T., Cusick, M. E., & Truong, N. N. (2018). Sources of self-efficacy and outcome expectations in science, technology, engineering, and mathematics domains: A meta-analysis. Journal of Vocational Behavior, 109, 118-136. https://doi.org/10.1016/j.jvb.2018.10.003
BACKGROUNDSisto A, Vicinanza F, Campanozzi LL, Ricci G, Tartaglini D, Tambone V. Towards a Transversal Definition of Psychological Resilience: A Literature Review. Medicina (Kaunas). 2019 Nov 16;55(11):745. doi: 10.3390/medicina55110745. PMID 31744109
BACKGROUNDSohrabei, S., & Atashi, A. (2021). The impact of mobile health on breast cancer patient's life and treatment: A systematic review. Frontiers in Health Informatics, 10(1), 88. https://doi.org/10.30699/fhi.v10i1.295
BACKGROUNDTan WS, Beatty L, Koczwara B. Do cancer patients use the term resilience? A systematic review of qualitative studies. Support Care Cancer. 2019 Jan;27(1):43-56. doi: 10.1007/s00520-018-4456-y. Epub 2018 Sep 12. PMID 30209600
BACKGROUNDvan Seijen M, Lips EH, Thompson AM, Nik-Zainal S, Futreal A, Hwang ES, Verschuur E, Lane J, Jonkers J, Rea DW, Wesseling J; PRECISION team. Ductal carcinoma in situ: to treat or not to treat, that is the question. Br J Cancer. 2019 Aug;121(4):285-292. doi: 10.1038/s41416-019-0478-6. Epub 2019 Jul 9. PMID 31285590
BACKGROUNDWagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78. PMID 7850498
BACKGROUNDWang Z, Cheng Y, Li J, Hu X. Effect of integrated medical and nursing intervention model on quality of life and unhealthy emotion of patients with esophageal cancer undergoing radiotherapy. Am J Transl Res. 2021 Apr 15;13(4):3780-3786. eCollection 2021. PMID 34017565
BACKGROUNDWang Z, Yin G, Jia R. Impacts of self-care education on adverse events and mental health related quality of life in breast cancer patients under chemotherapy. Complement Ther Med. 2019 Apr;43:165-169. doi: 10.1016/j.ctim.2019.01.027. Epub 2019 Feb 1. PMID 30935525
BACKGROUNDXu, Y. F., Xu, X. F., Song, K., Qiu, C., Zhang, X., & DI LI NU ER-RE, H. (2021). Effects of Extended Care Based on the WeChat Platform on Self-Efficacy and Quality of Life of Postoperative Breast Cancer Patients. Indian Journal of Pharmaceutical Sciences, 23-30. https://doi.org/10.36468/pharmaceutical-sciences.spl.165
BACKGROUNDZhou K, Li J, Li X. Effects of cyclic adjustment training delivered via a mobile device on psychological resilience, depression, and anxiety in Chinese post-surgical breast cancer patients. Breast Cancer Res Treat. 2019 Nov;178(1):95-103. doi: 10.1007/s10549-019-05368-9. Epub 2019 Jul 24. PMID 31342310
BACKGROUNDZhu J, Ebert L, Liu X, Wei D, Chan SW. Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Apr 30;6(4):e104. doi: 10.2196/mhealth.9438. PMID 29712622
DERIVEDHsu HT, Yu CN, Sun WN, Liang TY, Weng SF, Yu E, Hsu YF. Feasibility and Acceptability of a Mobile App Intervention to Promote Self-Efficacy and Resilience Among Breast Cancer Patients Undergoing Chemotherapy: A Pilot Randomized Controlled Trial. Psychooncology. 2025 Nov;34(11):e70331. doi: 10.1002/pon.70331. PMID 41217167