Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN)

Alexander Bauer, Dirk Vordermark, Thomas Seufferlein, Hans-Joachim Schmoll, Henning Dralle, Wilfried Mau, Susanne Unverzagt, Stephanie Boese, Eva-Maria Fach, Margarete Landenberger, Alexander Bauer, Dirk Vordermark, Thomas Seufferlein, Hans-Joachim Schmoll, Henning Dralle, Wilfried Mau, Susanne Unverzagt, Stephanie Boese, Eva-Maria Fach, Margarete Landenberger

Abstract

Background: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare.

Methods/design: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital.

Discussion: The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today's clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients.

Trial registration: ClinicalTrials.gov Identifier NCT01651832.

Figures

Fig. 1
Fig. 1
Study flowchart/CONSORT diagram
Fig. 2
Fig. 2
Time line and procedures

References

    1. Robert-Koch-Institut, Krebs in Deutschland 2009/2010. Eine gemeinsame Veröffentlichung des Robert Koch-Instituts und der Gesellschaft der epidemiologischen Krebsregister in Deutschland e. V. . 2013, Robert Koch-Institut: Berlin.
    1. Majek O, Gondos A, Jansen L, Emrich K, Holleczek B, Katalinic A, et al. Survival from colorectal cancer in Germany in the early 21st century. Br J Cancer. 2012;106(11):1875–80. doi: 10.1038/bjc.2012.189.
    1. Ahmed N, Ahmedzai S.H, Collins K, Noble B. Holistic assessment of supportive and palliative care needs: the evidence for routine systematic questioning. BMJ Support Palliat Care. 2014; 4(3):238-46. doi:10.1136/bmjspcare-2012-000324. Epub 2014.
    1. Hryniuk W, Simpson R, McGowan A, Carter P. Patient perceptions of a comprehensive cancer navigation service. Curr Oncol. 2014;21(2):69–76. doi: 10.3747/co.21.1930.
    1. Sanders SL, Bantum EO, Owen JE, Thornton AA, Stanton AL. Supportive care needs in patients with lung cancer. Psychooncology. 2010;19(5):480–9. doi: 10.1002/pon.1577.
    1. Yun YH, Shon EJ, Yang AJ, Kim SH, Kim YA, Chang YJ, et al. Needs regarding care and factors associated with unmet needs in disease-free survivors of surgically treated lung cancer. Ann Oncol. 2013;24(6):1552–9. doi: 10.1093/annonc/mdt032.
    1. Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, et al. Patients’ supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009;27(36):6172–9. doi: 10.1200/JCO.2009.22.5151.
    1. Li WW, Lam WW, Au AH, Ye M, Law WL, Poon J, et al. Interpreting differences in patterns of supportive care needs between patients with breast cancer and patients with colorectal cancer. Psychooncology. 2013;22(4):792–8. doi: 10.1002/pon.3068.
    1. Borjeson S, Starkhammar H, Unosson M, Bertero C, et al. Common Symptoms and Distress Experienced Among Patients with Colorectal Cancer: A Qualitative part of Mixed Method Design. Open Nurs J. 2012;6:100–7. doi: 10.2174/1874434601206010100.
    1. Harrison JD, Young JM, Price MA, Butow PN, Solomon MJ. What are the unmet supportive care needs of people with cancer? A systematic review. Support Care Cancer. 2009;17(8):1117–28. doi: 10.1007/s00520-009-0615-5.
    1. Jakobsson L, Hallberg IR, Loven L. Met and unmet nursing care needs in men with prostate cancer. An explorative study. Part II. Eur J Cancer Care (Engl) 1997;6(2):117. doi: 10.1046/j.1365-2354.1997.00020.x.
    1. Rinaldis M, Pakenham KI, Lynch BM. A structural model of the relationships among stress, coping, benefit-finding and quality of life in persons diagnosed with colorectal cancer. Psychol Health. 2012;27(2):159–77. doi: 10.1080/08870441003768047.
    1. Neugut AI, Matasar M, Wang X, McBride R, Jacobson JS, Tsai WY, et al. Duration of adjuvant chemotherapy for colon cancer and survival among the elderly. J Clin Oncol. 2006;24(15):2368–75. doi: 10.1200/JCO.2005.04.5005.
    1. Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche K., AWMF) S3-Leitlinie Kolorektales Karzinom, Langversion 1.0, AWMF Registrierungsnummer: 021-007OL, 2013.
    1. Andreyev HJ, Davidson SE, Gillespie C, Allum WH, Swarbrick E, et al. Practice guidance on the management of acute and chronic gastrointestinal problems arising as a result of treatment for cancer. Gut. 2012;61(2):179–92. doi: 10.1136/gutjnl-2011-300563.
    1. de Raaf PJ, de Klerk C, Timman R, Busschbach JJ, Oldenmenger WH, van der Rijt CC, et al. Systematic monitoring and treatment of physical symptoms to alleviate fatigue in patients with advanced cancer: a randomized controlled trial. J Clin Oncol. 2013;31(6):716–23. doi: 10.1200/JCO.2012.44.4216.
    1. Rosmarin D, Palles C, Church D, Domingo E, Jones A, Johnstone E, et al. Genetic Markers of Toxicity From Capecitabine and Other Fluorouracil-Based Regimens: Investigation in the QUASAR2 Study, Systematic Review, and Meta-Analysis. J Clin Oncol. 2014;32(10):1031–9. doi: 10.1200/JCO.2013.51.1857.
    1. Siassi M, Weiss M. Lebensqualität nach kolorektalen Operationen. coloproctology. 2011;33(4):222–227. doi: 10.1007/s00053-011-0185-0.
    1. Wulff C.N, Vedsted P, Sondergaard J. A randomised controlled trial of hospital-based case management to improve colorectal cancer patients’ health-related quality of life and evaluations of care. BMJ Open. 2012;2(6).pii:e001481. doi:10.1136/bmjopen-2012-001481.Print 2012.
    1. Weissflog G, Singer S, Meyer A, Wittekind C, Dietrich A, Weimann A, et al. Quality of life of colorectal cancer patients in certified centers versus non-certified hospitals. Onkologie. 2012;35(4):162–8. doi: 10.1159/000337362.
    1. Kent EE, Mitchell SA, Oakley-Girvan I, Arora NK. The importance of symptom surveillance during follow-up care of leukemia, bladder, and colorectal cancer survivors. Support Care Cancer. 2014;22(1):163–72. doi: 10.1007/s00520-013-1961-x.
    1. Graca-Pereira M, Figueiredo AP, Fincham FD. Anxiety, depression, traumatic stress and quality of life in colorectal cancer after different treatments: A study with Portuguese patients and their partners. Eur J Oncol Nurs. 2012;16(3):227–32. doi: 10.1016/j.ejon.2011.06.006.
    1. Howell DM, Sussman J, Wiernikowski J, Pyette N, Bainbridge D, O'Brien M, et al. A mixed-method evaluation of nurse-led community-based supportive cancer care. Support Care Cancer. 2008;16(12):1343–52. doi: 10.1007/s00520-008-0416-2.
    1. Ouwens M, Hulscher M, Hermens R, Faber M, Marres H, Wollersheim H, et al. Implementation of integrated care for patients with cancer: a systematic review of interventions and effects. Int J Qual Health Care. 2009;21(2):137–44. doi: 10.1093/intqhc/mzn061.
    1. Chen RC, Mamon HJ, Chen YH, Gelman RS, Suh WW, Talcott JA, et al. Patient-reported acute gastrointestinal symptoms during concurrent chemoradiation treatment for rectal cancer. Cancer. 2010;116(8):1879–86. doi: 10.1002/cncr.24963.
    1. Lewis R. Neal R.D, Williams N.H, France B, Wilkinson C, Hendry M, et al. Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic review. J Adv Nurs. 2009;65(4):706–23. doi: 10.1111/j.1365-2648.2008.04927.x.
    1. Efficace F, Bottomley A, Coens C, Van Steen K, Conroy T, Schoffski P, et al. Does a patient’s self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer? Eur J Cancer. 2006;42(1):42–9. doi: 10.1016/j.ejca.2005.07.025.
    1. Jahn P, Kitzmantel M, Renz P, Kukk E, Kuss O, Thoke-Colberg A, et al. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial. Trials. 2010;11(1):29. doi: 10.1186/1745-6215-11-29.
    1. Jahn P, Renz P, Stukenkemper J, Book K, Kuss O, Jordan K, et al. Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: a cluster-randomized multicenter trial. Support Care Cancer. 2009;17(12):1543–52. doi: 10.1007/s00520-009-0698-z.
    1. Jahn P, Kuss O, Schmidt H, Bauer A, Kitzmantel M, Jordan K, et al. Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: A cluster-randomized multicenter trial. Pain. 2014;155(4):746–54. doi: 10.1016/j.pain.2014.01.006.
    1. Wagner EH, Ludman EJ, Aiello Bowles EJ, Penfold R, Reid RJ, Rutter CM, et al. Nurse navigators in early cancer care: a randomized, controlled trial. J Clin Oncol. 2014;32(1):12–8. doi: 10.1200/JCO.2013.51.7359.
    1. Yokoo M, Akechi T, Takayama T, Karato A, Kikuuchi Y, Okamoto N, et al. Comprehensive Assessment of Cancer Patients’ Concerns and the Association with Quality of Life. Jpn J Clin Oncol. 2014;44(7):670–6. doi: 10.1093/jjco/hyu060.
    1. Sun V, Grant M, McMullen CK, Altschuler A, Mohler MJ, Hornbrook MC, et al. From diagnosis through survivorship: health-care experiences of colorectal cancer survivors with ostomies. Support Care Cancer. 2014;22(6):1563–70. doi: 10.1007/s00520-014-2118-2.
    1. Maguire R, Ream E, Richardson A, Connaghan J, Johnston B, Kotronoulas G, et al. Development of a Novel Remote Patient Monitoring System: The Advanced Symptom Management System for Radiotherapy to Improve the Symptom Experience of Patients With Lung Cancer Receiving Radiotherapy. Cancer Nurs. 2015;38(2):E37–47. doi: 10.1097/NCC.0000000000000150.
    1. Osoba D, Zee B, Pater J, Warr D, Kaizer L, Latreille L, et al. Psychometric properties and responsiveness of the EORTC Quality of Life Questionnaire (QLCW30) in patients with breast, ovarian and lung cancer. Qual Life Res. 1994;3:353–64. doi: 10.1007/BF00451727.
    1. Benson VS, Atkin WS, Green J, Nadel MR, Patnick J, Smith RA, et al. Toward standardizing and reporting colorectal cancer screening indicators on an international level: The International Colorectal Cancer Screening Network. Int J Cancer. 2012;130(12):2961–73. doi: 10.1002/ijc.26310.
    1. Brenner H, Chang-Claude J, Seiler CM, Rickert A, Hoffmeister M. Protection from colorectal cancer after colonoscopy: a population-based, case–control study. Ann Intern Med. 2011;154(1):22–30. doi: 10.7326/0003-4819-154-1-201101040-00004.
    1. Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005;365(9454):176–86. doi: 10.1016/S0140-6736(05)17709-5.
    1. Mayring P. Qualitative Inhaltsanalyse: Grundlagen und Techniken. Vol. 11th ed. (revised). 2010, Weinheim: Belz.
    1. Walshe KMJ: Principles for Best Practice in Clinical Audit. National Institute for Clinical Excellence. Abingdon, Oxon: Radcliffe Medical Press, 2002.
    1. Deutsches Netzwerk für Qualitätsentwicklung in der Pflege (DNQP), Expertenstandard Schmerzmanagement in der Pflege . Entwicklung -Konsentierung - Implementierung. Osnabrück: Deutsches Netzwerk für Qualitätsentwicklung in der Pflege; 2005.
    1. Gray NM, Hall SJ, Browne S, Macleod U, Mitchell E, Lee AJ, et al. Modifiable and fixed factors predicting quality of life in people with colorectal cancer. Br J Cancer. 2011;104(11):1697–703. doi: 10.1038/bjc.2011.155.
    1. Weaver A, Love SB, Larsen M, Shanyinde M, Waters R, Grainger L, et al. A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes. Support Care Cancer. 2014;22(10):2677–85. doi: 10.1007/s00520-014-2224-1.
    1. Carey M, Lambert S, Smits R, Paul C, Sanson-Fisher R, Clinton-McHarg T, et al. The unfulfilled promise: a systematic review of interventions to reduce the unmet supportive care needs of cancer patients. Support Care Cancer. 2012;20(2):207–19. doi: 10.1007/s00520-011-1327-1.
    1. Young JM, Butow PN, Walsh J, Durcinoska I, Dobbins TA, Rodwell L, et al. Multicenter randomized trial of centralized nurse-led telephone-based care coordination to improve outcomes after surgical resection for colorectal cancer: the CONNECT intervention. J Clin Oncol. 2013;31(28):3585–91. doi: 10.1200/JCO.2012.48.1036.
    1. Harrison JD, Young JM, Auld S, Masya L, Solomon MJ, Butow PN, et al. Quantifying postdischarge unmet supportive care needs of people with colorectal cancer: a clinical audit. Colorectal Dis. 2011;13(12):1400–6. doi: 10.1111/j.1463-1318.2010.02478.x.
    1. Zhang M, Chan SW, You L, Wen Y, Peng L, Liu W, et al. The effectiveness of a self-efficacy-enhancing intervention for Chinese patients with colorectal cancer: a randomized controlled trial with 6-month follow up. Int J Nurs Stud. 2014;51(8):1083–92. doi: 10.1016/j.ijnurstu.2013.12.005.
    1. Craven O, Hughes CA, Burton A, Saunders MP, Molassiotis A. Is a nurse-led telephone intervention a viable alternative to nurse-led home care and standard care for patients receiving oral capecitabine? Results from a large prospective audit in patients with colorectal cancer. Eur J Cancer Care (Engl) 2013;22(3):413–9. doi: 10.1111/ecc.12047.
    1. Molassiotis A, Brearley S, Saunders M, Craven O, Wardley A, Farrell C, et al. Effectiveness of a home care nursing program in the symptom management of patients with colorectal and breast cancer receiving oral chemotherapy: a randomized, controlled trial. J Clin Oncol. 2009;27(36):6191–8. doi: 10.1200/JCO.2008.20.6755.
    1. Reese JB, Blackford A, Sussman J, Okuyama T, Akechi T, Bainbridge D, et al. Cancer patients’ function, symptoms and supportive care needs: a latent class analysis across cultures. Qual Life Res. 2015;24(1):135–46. doi: 10.1007/s11136-014-0629-4.
    1. Dulko D, Pace CM, Dittus KL, Sprague BL, Pollack LA, Hawkins NA, et al. Barriers and facilitators to implementing cancer survivorship care plans. Oncol Nurs Forum. 2013;40(6):575–80. doi: 10.1188/13.ONF.575-580.
    1. Mitchell J, Khoukaz T, McNeal D, Brent L. Adverse event management strategies: optimizing treatment with regorafenib in patients with metastatic colorectal cancer. Clin J Oncol Nurs. 2014;18(2):E19–25. doi: 10.1188/14.CJON.E19-E25.
    1. Nakaguchi T, Okuyama T, Uchida M, Ito Y, Komatsu H, Wada M, et al. Oncology nurses’ recognition of supportive care needs and symptoms of their patients undergoing chemotherapy. Jpn J Clin Oncol. 2013;43(4):369–76. doi: 10.1093/jjco/hyt003.

Source: PubMed

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