Enhancing Cancer care of rural dwellers through telehealth and engagement (ENCORE): protocol to evaluate effectiveness of a multi-level telehealth-based intervention to improve rural cancer care delivery

Tuya Pal, Pamela C Hull, Tatsuki Koyama, Phillip Lammers, Denise Martinez, Jacob McArthy, Emma Schremp, Ann Tezak, Anne Washburn, Jennifer G Whisenant, Debra L Friedman, Tuya Pal, Pamela C Hull, Tatsuki Koyama, Phillip Lammers, Denise Martinez, Jacob McArthy, Emma Schremp, Ann Tezak, Anne Washburn, Jennifer G Whisenant, Debra L Friedman

Abstract

Background: Despite lower cancer incidence rates, cancer mortality is higher among rural compared to urban dwellers. Patient, provider, and institutional level factors contribute to these disparities. The overarching objective of this study is to leverage the multidisciplinary, multispecialty oncology team from an academic cancer center in order to provide comprehensive cancer care at both the patient and provider levels in rural healthcare centers. Our specific aims are to: 1) evaluate the clinical effectiveness of a multi-level telehealth-based intervention consisting of provider access to molecular tumor board expertise along with patient access to a supportive care intervention to improve cancer care delivery; and 2) identify the facilitators and barriers to future larger scale dissemination and implementation of the multi-level intervention.

Methods: Coordinated by a National Cancer Institute-designated comprehensive cancer center, this study will include providers and patients across several clinics in two large healthcare systems serving rural communities. Using a telehealth-based molecular tumor board, sequencing results are reviewed, predictive and prognostic markers are discussed, and treatment plans are formulated between expert oncologists and rural providers. Simultaneously, the rural patients will be randomized to receive an evidence-based 6-week self-management supportive care program, Cancer Thriving and Surviving, versus an education attention control. Primary outcomes will be provider uptake of the molecular tumor board recommendation and patient treatment adherence. A mixed methods approach guided by the Consolidated Framework for Implementation Research that combines qualitative key informant interviews and quantitative surveys will be collected from both the patient and provider in order to identify facilitators and barriers to implementing the multi-level intervention.

Discussion: The proposed study will leverage information technology-enabled, team-based care delivery models in order to deliver comprehensive, coordinated, and high-quality cancer care to rural and/or underserved populations. Simultaneous attention to institutional, provider, and patient level barriers to quality care will afford the opportunity for us to broadly share oncology expertise and develop dissemination and implementation strategies that will enhance the cancer care delivered to patients residing within underserved rural communities.

Trial registration: Clinicaltrials.gov , NCT04758338 . Registered 17 February 2021 - Retrospectively registered, http://www.clinicaltrials.gov/.

Keywords: Consolidated framework for implementation research (CFIR); Precision medicine; Virtual molecular tumor board.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Location of Participating Vanderbilt Health Affiliate Network sites serving rural counties within the VICC Catchment area. This figure illustrates the study’s catchment area throughout Tennessee and Mississippi, including a distinction between rural versus non-rural counties. Each number represents the location of one of nine participating hospitals through the Vanderbilt Health Affiliated Network (VHAN), including seven through the Baptist Memorial Health Care Corporation and two through Ballad Health. This figure was created by the authors specifically for this clinical trial protocol
Fig. 2
Fig. 2
Conceptual Framework: Implementation of Evidence-Based Cancer Care Delivery to Rural Populations via Telehealth. This figure illustrates the conceptual framework for implementation of the multi-level telehealth intervention to bring evidence-based comprehensive cancer care to patients in rural counties in Tennessee. The white blocks on the left indicate that we will evaluate the clinical effectiveness of delivering a multi-level telehealth intervention to rural hospitals to improve cancer care delivery, consisting of 1) provider-level access to tumor board expertise that incorporates disease, patient, and molecular tumor characteristics, and 2) patient-level access to a supportive care intervention (Aim 1). The dark gray block on the top right outlines the intervention outcomes. The gray blocks in the middle illustrate domains and subdomains of the CFIR that we will examine during intervention delivery to identify barriers and facilitators to future larger scale dissemination and implementation of the intervention (Aim 2)
Fig. 3
Fig. 3
Study schema. VICC, Vanderbilt-Ingram Cancer Center; HOPE, Hereditary and Oncologic Personalized Evaluation; CTS, Cancer Thriving and Surviving intervention; EMR, electronic medical record
Fig. 4
Fig. 4
Recruitment and surveys conducted at the provider level and patient level per study phase. The action and particular survey that will be completed by both the provider and patient for the Enrollment Phase, Tumor Board Phase, and Post-Intervention Phase is illustrated. MTB, molecular tumor board; CTS, Cancer Thriving and Surviving

References

    1. Henley SJ, Anderson RN, Thomas CC, Massetti GM, Peaker B, Richardson LC. Invasive Cancer incidence, 2004-2013, and deaths, 2006-2015, in nonmetropolitan and metropolitan counties - United States. MMWR Surveill Summ. 2017;66(14):1–13. doi: 10.15585/mmwr.ss6614a1.
    1. Blake KD, Moss JL, Gaysynsky A, Srinivasan S, Croyle RT. Making the Case for Investment in Rural Cancer Control: an analysis of rural Cancer incidence, mortality, and funding trends. Cancer Epidemiol Biomark Prev. 2017;26(7):992–997. doi: 10.1158/1055-9965.EPI-17-0092.
    1. Chow CJ, Al-Refaie WB, Abraham A, Markin A, Zhong W, Rothenberger DA, Kwaan MR, Habermann EB. Does patient rurality predict quality colon cancer care?: a population-based study. Dis Colon Rectum. 2015;58(4):415–422. doi: 10.1097/DCR.0000000000000173.
    1. Meilleur A, Subramanian SV, Plascak JJ, Fisher JL, Paskett ED, Lamont EB. Rural residence and cancer outcomes in the United States: issues and challenges. Cancer Epidemiol Biomark Prev. 2013;22(10):1657–1667. doi: 10.1158/1055-9965.EPI-13-0404.
    1. Singh GK, Williams SD, Siahpush M, Mulhollen A. Socioeconomic, rural-urban, and racial inequalities in US Cancer mortality: part I-all cancers and lung Cancer and part II-colorectal, prostate, breast, and cervical cancers. J Cancer Epidemiol. 2011;2011:107497–107427. doi: 10.1155/2011/107497.
    1. Kinney AY, Harrell J, Slattery M, Martin C, Sandler RS. Rural-urban differences in colon cancer risk in blacks and whites: the North Carolina Colon Cancer study. J Rural Health. 2006;22(2):124–130. doi: 10.1111/j.1748-0361.2006.00020.x.
    1. Hashibe M, Kirchhoff AC, Kepka D, Kim J, Millar M, Sweeney C, Herget K, Monroe M, Henry NL, Lopez AM, Mooney K. Disparities in cancer survival and incidence by metropolitan versus rural residence in Utah. Cancer Med. 2018;7(4):1490–1497. doi: 10.1002/cam4.1382.
    1. Zahnd WE, James AS, Jenkins WD, Izadi SR, Fogleman AJ, Steward DE, Colditz GA, Brard L. Rural-urban differences in Cancer incidence and trends in the United States. Cancer Epidemiol Biomark Prev. 2018;27(11):1265–1274. doi: 10.1158/1055-9965.EPI-17-0430.
    1. United States Census Bureau American Community Survey, 2011-2015. New Census Data Show Differences Between Urban and Rural Populations. [].
    1. National Rural Health Information. About Rural Health Care [].
    1. Weaver KE, Geiger AM, Lu L, Case LD. Rural-urban disparities in health status among US cancer survivors. Cancer. 2013;119(5):1050–1057. doi: 10.1002/cncr.27840.
    1. Charlton M, Schlichting J, Chioreso C, Ward M, Vikas P. Challenges of rural Cancer Care in the United States. Oncology (Williston Park) 2015;29(9):633–640.
    1. McDougall JA, Banegas MP, Wiggins CL, Chiu VK, Rajput A, Kinney AY. Rural disparities in treatment-related financial hardship and adherence to surveillance colonoscopy in diverse colorectal Cancer survivors. Cancer Epidemiol Biomark Prev. 2018;27(11):1275–1282. doi: 10.1158/1055-9965.EPI-17-1083.
    1. Andrykowski MA, Steffens RF, Bush HM, Tucker TC. Disparities in mental health outcomes among lung cancer survivors associated with ruralness of residence. Psycho-oncology. 2014;23(4):428–436. doi: 10.1002/pon.3440.
    1. Reid-Arndt SA, Cox CR. Does rurality affect quality of life following treatment for breast cancer? J Rural Health. 2010;26(4):402–405. doi: 10.1111/j.1748-0361.2010.00295.x.
    1. Unger JM, Moseley A, Symington B, Chavez-MacGregor M, Ramsey SD, Hershman DL. Geographic distribution and survival outcomes for rural patients with Cancer treated in clinical trials. JAMA Netw Open. 2018;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235.
    1. Spencer JC, Wheeler SB, Rotter JS, Holmes GM. Decomposing mortality disparities in urban and rural U.S. counties. Health Serv Res. 2018;53(6):4310–4331. doi: 10.1111/1475-6773.12982.
    1. Singh GK, Jemal A. Socioeconomic and racial/ethnic disparities in Cancer mortality, incidence, and survival in the United States, 1950-2014: over six decades of changing patterns and widening inequalities. J Environ Public Health. 2017;2017:2819372–2819319. doi: 10.1155/2017/2819372.
    1. Singh GK, Miller BA, Hankey BF. Changing area socioeconomic patterns in U.S. cancer mortality, 1950-1998: Part II--lung and colorectal cancers. J Natl Cancer Inst. 2002;94(12):916–925. doi: 10.1093/jnci/94.12.916.
    1. Institute of Medicine . The Role of Telehealth in an Evolving Health Care Environment. Washington, DC: The National Academies Press; 2012.
    1. Jue JS, Spector SA, Spector SA. Telemedicine broadening access to care for complex cases. J Surg Res. 2017;220:164–170. doi: 10.1016/j.jss.2017.06.085.
    1. Larson JL, Rosen AB, Wilson FA. The effect of telehealth interventions on quality of life of Cancer patients: a systematic review and Meta-analysis. Telemed J E Health. 2018;24(6):397–405. doi: 10.1089/tmj.2017.0112.
    1. Rocque GB, Halilova KI, Varley AL, Williams CP, Taylor RA, Masom DG, Wright WJ, Partridge EE, Kvale EA. Feasibility of a telehealth educational program on self-Management of Pain and Fatigue in adult Cancer patients. J Pain Symptom Manag. 2017;53(6):1071–1078. doi: 10.1016/j.jpainsymman.2016.12.345.
    1. Jaglal SB, Haroun VA, Salbach NM, Hawker G, Voth J, Lou W, Kontos P, Cameron JE, Cockerill R, Bereket T. Increasing access to chronic disease self-management programs in rural and remote communities using telehealth. Telemed J E Health. 2013;19(6):467–473. doi: 10.1089/tmj.2012.0197.
    1. Cox A, Lucas G, Marcu A, Piano M, Grosvenor W, Mold F, Maguire R, Ream E. Cancer Survivors' experience with telehealth: a systematic review and thematic synthesis. J Med Internet Res. 2017;19(1):e11. doi: 10.2196/jmir.6575.
    1. Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE randomized controlled trial. J Clin Oncol. 2014;32(7):654–662. doi: 10.1200/JCO.2013.51.6765.
    1. Myers Virtue S, Howrey HL, Duffy NM, Wallace M. Shifting psychosocial oncology care to telepsychology during the COVID-19 pandemic. J Psychosoc Oncol. 2021;39(3):416–427. doi: 10.1080/07347332.2021.1894526.
    1. Berlin A, Lovas M, Truong T, Melwani S, Liu J, Liu ZA, Badzynski A, Carpenter MB, Virtanen C, Morley L, Bhattacharyya O, Escaf M, Moody L, Goldfarb A, Brzozowski L, Cafazzo J, Chua MLK, Stewart AK, Krzyzanowska MK. Implementation and outcomes of virtual care across a tertiary Cancer center during COVID-19. JAMA Oncol. 2021;7(4):597–602. doi: 10.1001/jamaoncol.2020.6982.
    1. Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021;29(8):4191–4194. doi: 10.1007/s00520-021-06174-0.
    1. Royce TJ, Sanoff HK, Rewari A. Telemedicine for Cancer Care in the Time of COVID-19. JAMA Oncol. 2020;6(11):1698–1699. doi: 10.1001/jamaoncol.2020.2684.
    1. Ben-Arye E, Paller CJ, Lopez AM, White S, Pendleton E, Kienle GS, Samuels N, Abbawaajii N, Balneaves LG. The Society for Integrative Oncology Practice Recommendations for online consultation and treatment during the COVID-19 pandemic. Support Care Cancer. 2021;29(10):6155–6165. doi: 10.1007/s00520-021-06205-w.
    1. Stevenson MM, Irwin T, Lowry T, Ahmed MZ, Walden TL, Watson M, Sutton L. Development of a virtual multidisciplinary lung cancer tumor board in a community setting. J Oncol Pract. 2013;9(3):e77–e80. doi: 10.1200/JOP.2013.000882.
    1. Louis JS, Bukowski A, Rodrigues AN, Moreno J, Ferreyra M, Lopes A, Serna FDL, Tindwa CH, Mollah OB, Villarreal-Garza C, et al. Global Cancer Institute multidisciplinary tumor boards as a tool to improve patterns of clinical practice for breast and gynecologic cancer in resource-limited settings. J Clin Oncol. 2017;35(15_suppl):6556. doi: 10.1200/JCO.2017.35.15_suppl.6556.
    1. El Saghir NS, Keating NL, Carlson RW, Khoury KE, Fallowfield L. Tumor boards: optimizing the structure and improving efficiency of multidisciplinary management of patients with cancer worldwide. Am Soc Clin Oncol Educ Book. 2014;(34):e461–6. 10.14694/EdBook_AM.2014.34.e461.
    1. Dalton WB, Forde PM, Kang H, Connolly RM, Stearns V, Gocke CD, Eshleman JR, Axilbund J, Petry D, Geoghegan C, et al. Personalized Medicine in the Oncology Clinic: Implementation and Outcomes of the Johns Hopkins Molecular Tumor Board. JCO Precis Oncol. 2017;2017(1):1–19. doi: 10.1200/PO.16.00046.
    1. Rody A, Ettl J, Marme F, Prat A. Molecular Tumor Boards. Breast Care (Basel) 2018;13(2):141–143. doi: 10.1159/000489138.
    1. Schwaederle M, Parker BA, Schwab RB, Fanta PT, Boles SG, Daniels GA, Bazhenova LA, Subramanian R, Coutinho AC, Ojeda-Fournier H, Datnow B, Webster NJ, Lippman SM, Kurzrock R. Molecular tumor board: the University of California-san Diego Moores Cancer Center experience. Oncologist. 2014;19(6):631–636. doi: 10.1634/theoncologist.2013-0405.
    1. Barr VJ, Robinson S, Marin-Link B, Underhill L, Dotts A, Ravensdale D, Salivaras S. The expanded chronic care model: an integration of concepts and strategies from population health promotion and the chronic care model. Hosp Q. 2003;7(1):73–82. doi: 10.12927/hcq.2003.16763.
    1. Coffey L, Mooney O, Dunne S, Sharp L, Timmons A, Desmond D, O'Sullivan E, Timon C, Gooberman-Hill R, Gallagher P. Cancer survivors' perspectives on adjustment-focused self-management interventions: a qualitative meta-synthesis. J Cancer Surviv. 2016;10(6):1012–1034. doi: 10.1007/s11764-016-0546-3.
    1. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1–7. doi: 10.1207/S15324796ABM2601_01.
    1. Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998;1(1):2–4.
    1. Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health affairs (Project Hope) 2001;20(6):64–78. doi: 10.1377/hlthaff.20.6.64.
    1. Bantum EO, Albright CL, White KK, Berenberg JL, Layi G, Ritter PL, Laurent D, Plant K, Lorig K. Surviving and thriving with cancer using a web-based health behavior change intervention: randomized controlled trial. J Med Internet Res. 2014;16(2):e54. doi: 10.2196/jmir.3020.
    1. Foster C, Grimmett C, May CM, Ewings S, Myall M, Hulme C, Smith PW, Powers C, Calman L, Armes J, Breckons M, Corner J, Fenlon D, Batehup L, Lennan E, R. May C, Morris C, Neylon A, Ream E, Turner L, Yardley L, Richardson A. A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-Centre proof of concept randomised controlled trial. Support Care Cancer. 2016;24(6):2445–2453. doi: 10.1007/s00520-015-3044-7.
    1. Gao WJ, Yuan CR. Self-management programme for cancer patients: a literature review. Int Nurs Rev. 2011;58(3):288–295. doi: 10.1111/j.1466-7657.2011.00907.x.
    1. Howell D, Harth T, Brown J, Bennett C, Boyko S. Self-management education interventions for patients with cancer: a systematic review. Support Care Cancer. 2017;25(4):1323–1355. doi: 10.1007/s00520-016-3500-z.
    1. McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH. Self-management: enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin. 2011;61(1):50–62. doi: 10.3322/caac.20093.
    1. Risendal BC, Dwyer A, Seidel RW, Lorig K, Coombs L, Ory MG. Meeting the challenge of cancer survivorship in public health: results from the evaluation of the chronic disease self-management program for cancer survivors. Front Public Health. 2014;2:214. doi: 10.3389/fpubh.2014.00214.
    1. Erdem E, Korda H. Self-management program participation by older adults with diabetes: chronic disease self-management program and diabetes self-management program. Fam Community Health. 2014;37(2):134–146. doi: 10.1097/FCH.0000000000000025.
    1. Brady TJ, Murphy L, O'Colmain BJ, Beauchesne D, Daniels B, Greenberg M, House M. Chervin D. A meta-analysis of health status, health behaviors, and health care utilization outcomes of the chronic disease self-management program. Prev Chronic Dis. 2013;10:120112. doi: 10.5888/pcd10.120112.
    1. Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Rogers A. The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007;61(3):254–261. doi: 10.1136/jech.2006.053538.
    1. Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW, Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001;39(11):1217–1223. doi: 10.1097/00005650-200111000-00008.
    1. Smith ML, Towne SD, Herrera-Venson A, Cameron K, Kulinski KP, Lorig K, et al. Dissemination of Chronic Disease Self-Management Education (CDSME) Programs in the United States: Intervention Delivery by Rurality. Int J Environ Res Public Health. 2017;14(6). 10.3390/ijerph14060638.
    1. Risendal B, Dwyer A, Seidel R, Lorig K, Katzenmeyer C, Coombs L, Kellar-Guenther Y, Warren L, Franco A, Ory M. Adaptation of the chronic disease self-management program for cancer survivors: feasibility, acceptability, and lessons for implementation. J Cancer Educ. 2014;29(4):762–771. doi: 10.1007/s13187-014-0652-8.
    1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4(1):50. doi: 10.1186/1748-5908-4-50.
    1. Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10(1):53. doi: 10.1186/s13012-015-0242-0.
    1. U.S. Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, based on 2019 submission data (1999–2017): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute [].
    1. Consolidated Framework for Implementation Research. Center for Clinical Management Research. [].
    1. Breitenstein SM, Fogg L, Garvey C, Hill C, Resnick B, Gross D. Measuring implementation fidelity in a community-based parenting intervention. Nurs Res. 2010;59(3):158–165. doi: 10.1097/NNR.0b013e3181dbb2e2.
    1. V. B, Clarke V Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Kalichman SC, Amaral CM, Swetzes C, Jones M, Macy R, Kalichman MO, Cherry C. A simple single-item rating scale to measure medication adherence: further evidence for convergent validity. J Int Assoc Physicians AIDS Care (Chic) 2009;8(6):367–374. doi: 10.1177/1545109709352884.
    1. National Comprehensive Cancer Network. Distress Thermometer Scale. [].
    1. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The functional assessment of Cancer therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570–579. doi: 10.1200/JCO.1993.11.3.570.
    1. Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson symptom inventory. Cancer. 2000;89(7):1634–1646. doi: 10.1002/1097-0142(20001001)89:7<1634::AID-CNCR29>;2-V.
    1. Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the communication assessment tool. Patient Educ Couns. 2007;67(3):333–342. doi: 10.1016/j.pec.2007.05.005.

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