Stepped care targeting psychological distress in head and neck and lung cancer patients: a randomized clinical trial

Anne-Marie H Krebber, C René Leemans, Remco de Bree, Annemieke van Straten, Filip Smit, Egbert F Smit, Annemarie Becker, Guus M Eeckhout, Aartjan T F Beekman, Pim Cuijpers, Irma M Verdonck-de Leeuw, Anne-Marie H Krebber, C René Leemans, Remco de Bree, Annemieke van Straten, Filip Smit, Egbert F Smit, Annemarie Becker, Guus M Eeckhout, Aartjan T F Beekman, Pim Cuijpers, Irma M Verdonck-de Leeuw

Abstract

Background: Psychological distress is common in cancer survivors. Although there is some evidence on effectiveness of psychosocial care in distressed cancer patients, referral rate is low. Lack of adequate screening instruments in oncology settings and insufficient availability of traditional models of psychosocial care are the main barriers. A stepped care approach has the potential to improve the efficiency of psychosocial care. The aim of the study described herein is to evaluate efficacy of a stepped care strategy targeting psychological distress in cancer survivors.

Methods/design: The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention programme versus care as usual. Patients treated for head and neck cancer (HNC) or lung cancer (LC) are screened for distress using OncoQuest, a computerized touchscreen system. After stratification for tumour (HNC vs. LC) and stage (stage I/II vs. III/IV), 176 distressed patients are randomly assigned to the intervention or control group. Patients in the intervention group will follow a stepped care model with 4 evidence based steps: 1. Watchful waiting, 2. Guided self-help via Internet or a booklet, 3. Problem Solving Treatment administered by a specialized nurse, and 4. Specialized psychological intervention or antidepressant medication. In the control group, patients receive care as usual which most often is a single interview or referral to specialized intervention. Primary outcome is the Hospital Anxiety and Depression Scale (HADS). Secondary outcome measures are a clinical level of depression or anxiety (CIDI), quality of life (EQ-5D, EORTC QLQ-C30, QLQ-HN35, QLQ-LC13), patient satisfaction with care (EORTC QLQ-PATSAT), and costs (health care utilization and work loss (TIC-P and PRODISQ modules)). Outcomes are evaluated before and after intervention and at 3, 6, 9 and 12 months after intervention.

Discussion: Stepped care is a system of delivering and monitoring treatments, such that effective, yet least resource-intensive, treatment is delivered to patients first. The main aim of a stepped care approach is to simplify the patient pathway, provide access to more patients and to improve patient well-being and cost reduction by directing, where appropriate, patients to low cost (self-)management before high cost specialist services.

Trial registration: NTR1868.

Figures

Figure 1
Figure 1
Overview of the stepped care programme.

References

    1. Comprehensive Cancer Centre The Netherlands (IKNL) Netherlands Cancer Registry. Incidence of head and neck cancer and lung cancer. [ . 2011. Ref Type: Online Source.
    1. Hopwood P, Stephens RJ. Depression in patients with lung cancer: prevalence and risk factors derived from quality-of-life data. J Clin Oncol. 2000;18:893–903.
    1. Hutton JM, Williams M. An investigation of psychological distress in patients who have been treated for head and neck cancer. Br J Oral Maxillofac Surg. 2001;39:333–339. doi: 10.1054/bjom.2001.0645.
    1. Rolke HB, Bakke PS, Gallefoss F. Health related quality of life, mood disorders and coping abilities in an unselected sample of patients with primary lung cancer. Respir Med. 2008;102:1460–1467. doi: 10.1016/j.rmed.2008.04.002.
    1. de Graeff A, de Leeuw JR, Ros WJ, Hordijk GJ, Blijham GH, Winnubst JA. Long-term quality of life of patients with head and neck cancer. Laryngoscope. 2000;110:98–106. doi: 10.1097/00005537-200001000-00018.
    1. Hammerlid E, Ahlner-Elmqvist M, Bjordal K, Biorklund A, Evensen J, Boysen M. et al.A prospective multicentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients. Br J Cancer. 1999;80:766–774. doi: 10.1038/sj.bjc.6690420.
    1. Bjordal K, Kaasa S. Psychological distress in head and neck cancer patients 7–11 years after curative treatment. Br J Cancer. 1995;71:592–597. doi: 10.1038/bjc.1995.115.
    1. Karnell LH, Funk GF, Christensen AJ, Rosenthal EL, Magnuson JS. Persistent posttreatment depressive symptoms in patients with head and neck cancer. Head Neck. 2006;28:453–461. doi: 10.1002/hed.20370.
    1. Verdonck-de Leeuw IM, Eerenstein SE, Van der Linden MH, Kuik DJ, de Bree R, Leemans CR. Distress in spouses and patients after treatment for head and neck cancer. Laryngoscope. 2007;117:238–241. doi: 10.1097/01.mlg.0000250169.10241.58.
    1. Fulcher CD, Badger T, Gunter AK, Marrs JA, Reese JM. Putting evidence into practice: interventions for depression. Clin J Oncol Nurs. 2008;12:131–140. doi: 10.1188/08.CJON.131-140.
    1. Osborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatr Med. 2006;36:13–34. doi: 10.2190/EUFN-RV1K-Y3TR-FK0L.
    1. Lepore SJ, Coyne JC. Psychological interventions for distress in cancer patients: a review of reviews. Ann Behav Med. 2006;32:85–92. doi: 10.1207/s15324796abm3202_2.
    1. Rodin G. Treatment of depression in patients with cancer. Lancet. 2008;372:8–10. doi: 10.1016/S0140-6736(08)60968-X.
    1. Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L. et al.High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004;90:2297–2304.
    1. Verdonck-de Leeuw IM, de Bree R, Keizer AL, Houffelaar T, Cuijpers P, van der Linden MH. et al.Computerized prospective screening for high levels of emotional distress in head and neck cancer patients and referral rate to psychosocial care. Oral Oncol. 2009;45:e129–e133. doi: 10.1016/j.oraloncology.2009.01.012.
    1. Carlson LE, Bultz BD. Efficacy and medical cost offset of psychosocial interventions in cancer care: making the case for economic analyses. Psychooncology. 2004;13:837–849. doi: 10.1002/pon.832.
    1. Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005;186:11–17. doi: 10.1192/bjp.186.1.11.
    1. Spijker J, Bijl RV, De Graaf R, Nolen WA. Care utilization and outcome of DSM-III-R major depression in the general population. Results from the Netherlands Mental Health Survey and Incidence Study (NEMESIS) Acta Psychiatr Scand. 2001;104:19–24. doi: 10.1034/j.1600-0447.2001.00363.x.
    1. van Straten A, Cuijpers P, Smits N. Effectiveness of a web-based self-help intervention for symptoms of depression, anxiety, and stress: randomized controlled trial. J Med Internet Res. 2008;10:e7. doi: 10.2196/jmir.954.
    1. Cuijpers P, van Straten A, Warmerdam L. Problem solving therapies for depression: a meta-analysis. Eur Psychiatr. 2007;22:9–15. doi: 10.1016/j.eurpsy.2006.11.001.
    1. Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007;37:319–328. doi: 10.1017/S0033291706008944.
    1. Mynors-Wallis L, Davies I, Gray A, Barbour F, Gath D. A randomised controlled trial and cost analysis of problem-solving treatment for emotional disorders given by community nurses in primary care. Br J Psychiatry. 1997;170:113–119. doi: 10.1192/bjp.170.2.113.
    1. Mynors-Wallis LM, Gath DH, Day A, Baker F. Randomised controlled trial of problem solving treatment, antidepressant medication, and combined treatment for major depression in primary care. BMJ. 2000;320:26–30. doi: 10.1136/bmj.320.7226.26.
    1. Strong V, Waters R, Hibberd C, Murray G, Wall L, Walker J. et al.Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. Lancet. 2008;372:40–48. doi: 10.1016/S0140-6736(08)60991-5.
    1. Catalan J, Gath DH, Anastasiades P, Bond SA, Day A, Hall L. Evaluation of a brief psychological treatment for emotional disorders in primary care. Psychol Med. 1991;21:1013–1018. doi: 10.1017/S0033291700030002.
    1. Hegel MT, Imming J, Cyr-Provost M. Role of behavioral health professionals in a collaborative stepped care treatment model for depression in primary care: project IMPACT. Fam Syst Health. 2002;20:265–277.
    1. Hegel MT, Oxman TE, Hull JG, Swain K, Swick H. Watchful waiting for minor depression in primary care: remission rates and predictors of improvement. Gen Hosp Psychiatr. 2006;28:205–212. doi: 10.1016/j.genhosppsych.2006.02.008.
    1. Mynors-Wallis LM, Gath DH, Lloyd-Thomas AR, Tomlinson D. Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care. BMJ. 1995;310:441–445. doi: 10.1136/bmj.310.6977.441.
    1. Katz MR, Kopek N, Waldron J, Devins GM, Tomlinson G. Screening for depression in head and neck cancer. Psychooncology. 2004;13:269–280. doi: 10.1002/pon.734.
    1. Walker J, Postma K, McHugh GS, Rush R, Coyle B, Strong V. et al.Performance of the Hospital Anxiety and Depression Scale as a screening tool for major depressive disorder in cancer patients. J Psychosom Res. 2007;63:83–91. doi: 10.1016/j.jpsychores.2007.01.009.
    1. Vodermaier A, Linden W, Siu C. Screening for emotional distress in cancer patients: a systematic review of assessment instruments. J Natl Canc Inst. 2009;101:1464–1488. doi: 10.1093/jnci/djp336.
    1. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27:363–370. doi: 10.1017/S0033291796004382.
    1. European Organisation for Research and Treatment of Cancer. [ . 2009. Ref Type: Online Source.
    1. Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de GA, Boysen M, Evensen JF. et al.Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999;17:1008–1019.
    1. Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S. et international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32) Eur J Cancer. 2005;41:2120–2131. doi: 10.1016/j.ejca.2005.04.041.
    1. Brooks R. EuroQol: the current state of play. Health Pol. 1996;37:53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. Group EuroQol. Euroqol - a new facility for the measurement of health related quality of life. Health Pol. 1990;16:199–208.
    1. van Roijen LH, van SA, Al M, Rutten F, Donker M. Cost-utility of brief psychological treatment for depression and anxiety. Br J Psychiatry. 2006;188:323–329. doi: 10.1192/bjp.188.4.323.
    1. Oostenbrink JB, Bouwmans CAM, Koopmanschap MA. Manual for Costing: Methods and standard costs for economic evaluations in health care. Diemen: Health Insurance Board; 2004. Ref Type: Report.
    1. Oostenbrink JB, Meerding WJ, Evers S, PRODISQ. PROductivity and DISease Questionnaire. Rotterdam/Maastricht; 2004. Ref Type: Report.
    1. Piccirillo JF. Impact of comorbidity and symptoms on the prognosis of patients with oral carcinoma. Arch Otolaryngol Head Neck Surg. 2000;126:1086–1088.
    1. World Health Organisation. Composite International Diagnostic Interview (CIDI) (version 1.0) Geneva: WHO; 1990.
    1. Wittchen HU. Reliability and validity studies of the WHO–Composite International Diagnostic Interview (CIDI): a critical review. J Psychiatr Res. 1994;28:57–84. doi: 10.1016/0022-3956(94)90036-1.
    1. Oostenbrink J. Standardisation of costs: the Dutch Manual for Costing in economic evaluations. PharmacoEconomics. 2002;20(7):443–454. doi: 10.2165/00019053-200220070-00002. Ref Type: Report.
    1. Langley PC. The November 1995 revised Australian guidelines for the economic evaluation of pharmaceuticals. PharmacoEconomics. 1996;9:341–352. doi: 10.2165/00019053-199609040-00007.
    1. Torrance GW, Blaker D, Detsky A, Kennedy W, Schubert F, Menon D. et al.Canadian guidelines for economic evaluation of pharmaceuticals. Canadian Collaborative Workshop for Pharmacoeconomics. PharmacoEconomics. 1996;9:535–559. doi: 10.2165/00019053-199609060-00008.
    1. Brouwer WB, Koopmanschap MA, Rutten FF. Productivity losses without absence: measurement validation and empirical evidence. Health Pol. 1999;48:13–27. doi: 10.1016/S0168-8510(99)00028-7.
    1. van Hout BA, Al MJ, Gordon GS, Rutten FF. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;3:309–319. doi: 10.1002/hec.4730030505.
    1. van Straten A, Geraedts A, Verdonck-de Leeuw I, Andersson G, Cuijpers P. Psychological treatment of depressive symptoms in patients with medical disorders: a meta-analysis. J Psychosom Res. 2010;69:23–32. doi: 10.1016/j.jpsychores.2010.01.019.
    1. Jacobsen PB. Screening for psychological distress in cancer patients: challenges and opportunities. J Clin Oncol. 2007;25:4526–4527. doi: 10.1200/JCO.2007.13.1367.
    1. Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE. Screening and referral for psychosocial distress in oncologic practice: use of the Distress Thermometer. Cancer. 2008;113:870–878. doi: 10.1002/cncr.23622.
    1. Valderas JM, Alonso J, Guyatt GH. Measuring patient-reported outcomes: moving from clinical trials into clinical practice. Med J Aust. 2008;189:93–94.
    1. Snyder CF, Aaronson NK. Use of patient-reported outcomes in clinical practice. Lancet. 2009;374:369–370. doi: 10.1016/S0140-6736(09)61400-8.
    1. Luckett T, Butow PN, King MT. Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Psychooncology. 2009;18:1129–1138. doi: 10.1002/pon.1545.
    1. McLachlan SA, Allenby A, Matthews J, Wirth A, Kissane D, Bishop M. et al.Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. J Clin Oncol. 2001;19:4117–4125.
    1. 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;288:3027–3034. doi: 10.1001/jama.288.23.3027.
    1. Velikova G, Brown JM, Smith AB, Selby PJ. Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer. 2002;86:51–59. doi: 10.1038/sj.bjc.6600001.
    1. Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new millennium. Health Aff (Millwood ) 2009;28:75–85. doi: 10.1377/hlthaff.28.1.75.
    1. van den Brink JL, Moorman PW, de Boer MF, Hop WC, Pruyn JF, Verwoerd CD. et al.Impact on quality of life of a telemedicine system supporting head and neck cancer patients: a controlled trial during the postoperative period at home. J Am Med Inform Assoc. 2007;14:198–205. doi: 10.1197/jamia.M2199.
    1. Ouwens MM, Hermens RR, Hulscher MM, Merkx MA, van den Hoogen FJ, Grol RP. et al.Impact of an integrated care program for patients with head and neck cancer on the quality of care. Head Neck. 2009;31:902–910. doi: 10.1002/hed.21041.
    1. Fillion L, de SM, Cook S, Goupil RL, Bairati I, Doll R. Professional patient navigation in head and neck cancer. Semin Oncol Nurs. 2009;25:212–221. doi: 10.1016/j.soncn.2009.05.004.
    1. de Bree R, Verdonck-de Leeuw IM, Keizer AL, Houffelaar A, Leemans CR. Touch screen computer-assisted health-related quality of life and distress data collection in head and neck cancer patients. Clin Otolaryngol. 2008;33:138–142. doi: 10.1111/j.1749-4486.2008.01676.x.
    1. CBO NWHHT. Nation-wide Guideline Laryngeal cancer, version 3.0. 2010. Ref Type: Report.
    1. CBO NVALT. Nation-wide Guideline Lung cancer, version 1.0. 2004. Ref Type: Report.
    1. CBO NWHHT. Nation-wide Guideline Oral Cavity and Oropharyngeal Cancer, version 1.4. 2004. Ref Type: Report.
    1. CBO NWHHT. Nation-wide Guideline Hypopharyngeal Cancer, version 2.0. 2010. Ref Type: Report.

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