The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial

Trials

Roy FPM Kruitwagen^1,13  Jan A Roukema^1,12  Johannes J van Beek⁵  Willem E Nolting⁶  Helena JMM Mertens¹  Harrie WH Feijen⁸  Brenda M Pijlman⁹  Joke E Haartsen⁴  Karin CM Engelhart²  Ralph HM Hermans^1,14  Erik A Boss⁷  Nicole PM Ezendam^1,11  Olga Husson^1,11  Dorry Boll³  Johanna MA Pijnenborg³  Maria C Vos^1,10  Kim AH Nicolaije^1,11  Lonneke V van de Poll-Franse^1,11 

[1]Department of Gynecology, Orbis Medical Center, Sittard, The Netherlands

[2]Department of Gynecology, St. Anna Hospital, Geldrop and Eindhoven, The Netherlands

[3]Department of Gynecology, TweeSteden Hospital, Tilburg and Waalwijk, The Netherlands

[4]Department of Gynecology, Elkerliek Hospital, Helmond, The Netherlands

[5]Department of Gynecology, VieCuri Hospital, Venlo and Venray, The Netherlands

[6]Department of Gynecology, St. Jans Hospital, Weert, The Netherlands

[7]Department of Gynecology, Maxima Medical Center, Veldhoven and Eindhoven, The Netherlands

[8]Department of Gynecology, Amphia Hospital, Breda and Oosterhout, The Netherlands

[9]Department of Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands

[10]Department of Gynecology, St. Elisabeth Hospital, Tilburg, The Netherlands

[11]Eindhoven Cancer Registry, Comprehensive Cancer Center South (CCCS), Eindhoven, The Netherlands

[12]Department of Surgery, St. Elisabeth Hospital, Tilburg, The Netherlands

[13]Department of Gynecology and GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands

[14]Department of Gynecology, Catharina Hospital, Eindhoven, The Netherlands

关键词: Health- Related Quality of Life;    Satisfaction with care;    Satisfaction with information provision;    Patient Reported Outcomes;    Health care providers;    Ovarian cancer;    Endometrial cancer;    Gynecological cancer survivors;    Pragmatic cluster randomized controlled trial;    Survivorship Care Plan;   

Others  :  1095751
DOI  :  10.1186/1745-6215-12-256

 received in 2011-09-12, accepted in 2011-12-05,  发布年份 2011

【 摘 要 】

Background

There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal document, and includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion. Until now, evidence on the effects of implementing the SCP in clinical practice is lacking. The rationale and study design of a pragmatic cluster randomized trial, aiming to assess the impact of SCP care in routine clinical practice, is presented.

Methods/Design

A web-based patient registration system 'Registrationsystem Oncological GYnecology' (ROGY) is used by gynecologists in the South of the Netherlands since 2006. A personalized SCP can automatically be generated out of ROGY. In this pragmatic cluster randomized controlled trial, 12 hospitals are randomized to either 'usual care' or 'SCP care'. In patients with 'usual care', the gynecologist provides care as usual. In patients with 'SCP care', information about the tumor stage and treatment is personally discussed with the patient and a document is handed to the patient. Prospectively, all patients diagnosed with endometrial or ovarian cancer in the participating hospitals will be approached for study participation. Patients will complete questionnaires after surgery, and before additional treatment, and after 6, 12, 18 and 24 months. In addition, health care providers will be asked their opinion about implementation of SCP care. Primary outcome is defined as patient satisfaction with information provision and care. Secondary outcomes are illness perception, health-related quality of life, health care use, prevalence, course and referral rate of survivors with psychosocial distress, and health care providers' evaluation of SCP care.

Discussion

The ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors.

Trial registration

Trial Registration: http://www.ClinicalTrials.gov webcite. Identifier: NCT01185626

Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743

【 授权许可】

   
2011 van de Poll-Franse et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Signaleringscommissie kanker van KWF Kankerbestrijding: Kanker in Nederland. Trends, prognoses en implicaties voor zorgvraag. Amsterdam; 2004.
• [2]Ayanian JZ, Jacobsen PB: Enhancing research on cancer survivors. J Clin Oncol 2006, 24:5149-5153.
• [3]Gotay CC, Muraoka MY: Quality of life in long-term survivors of adult-onset cancers. J Natl Cancer Inst 1998, 90:656-667.
• [4]Health Council of the Netherlands: Follow-up in oncology. Identify objectives, substantiate actions. The Hague; 2007.
• [5]Mesters I, van den Borne B, De Boer M, Pruyn J: Measuring information needs among cancer patients. Patient Educ Couns 2001, 43:253-262.
• [6]Davies NJ, Kinman G, Thomas RJ, Bailey T: Information satisfaction in breast and prostate cancer patients: implications for quality of life. Psychooncology 2008, 17:1048-1052.
• [7]Hesse BW, Arora NK, Burke Beckjord E, Finney Rutten LJ: Information support for cancer survivors. Cancer 2008, 112:2529-2540.
• [8]Meredith C, Symonds P, Webster L, Lamont D, Pyper E, Gillis CR, Fallowfield L: Information needs of cancer patients in west Scotland: cross sectional survey of patients' views. BMJ 1996, 313:724-726.
• [9]Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW: Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv 2008, 2:179-189.
• [10]Jenkins V, Fallowfield L, Saul J: Information needs of patients with cancer: results from a large study in UK cancer centres. Br J Cancer 2001, 84:48-51.
• [11]Lagarde SM, Franssen SJ, van Werven JR, Smets EM, Tran TC, Tilanus HW, Plukker JT, de Haes JC, van Lanschot JJ: Patient preferences for the disclosure of prognosis after esophagectomy for cancer with curative intent. Ann Surg Oncol 2008, 15:3289-3298.
• [12]Husson O, Mols F, van de Poll-Franse LV: The relation between information provision and health-related quality of life, anxiety and depression among cancer survivors: a systematic review. Annals of Oncology, in press.
• [13]Hewitt M, Greenfield S, Stovall E: From cancer patient to cancer survivor: Lost in transition. Washington, DC; 2006.
• [14]Tan ASL, Bourgoin A, Gray SW, Armstrong K, Hornik RC: How does patient-clinician information engagement influence self-reported cancer-related problems? Cancer, in press.
• [15]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390.
• [16]Campbell MK, Elbourne DR, Altman DG, for the CONSORT group: CONSORT statement: extension to cluster randomized trials. BMJ 2004, 328:702-708.
• [17]van de Poll-Franse LV, Horevoorts N, van Eenbergen M, Denollet J, Roukema JA, Aaronson NK, Coebergh JW, de Vries J, Essink-Bot M-L, Mols F: The Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship registry: Scope, rationale and design of an infrastructure for the study of physical and psychosocial outcomes in cancer survivorship cohorts. Eur J Cancer 2011, in press.
• [18]Schellings R, Kessels AG, Sturmans F: Pre-randomisation in study designs: getting past the taboo. Ned Tijdschr Geneeskd 2008, 152:2053-2056.
• [19]Ganz PA, Hahn EE: Implementing a survivorship care plan for patients with breast cancer. J Clin Oncol 2008, 26:759-767.
• [20]Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JEHM: Screening and referral for psychosocial distress in oncologic practice: Use of the Distress Thermometer. Cancer 2008, 113:870-878.
• [21]Arraras JI, Kuljanic-Vlasic K, Bjordal K, Yun YH, Efficace F, Holzner B, Mills J, Greimel E, Krauss O, Velikova G: EORTC QLQ-INFO26: a questionnaire to assess information given to cancer patients a preliminary analysis in eight countries. Psychooncology 2007, 16:249-254.
• [22]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, Kaasa S, Klee M, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F: The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
• [23]Greimel E, Nordin A, Lanceley A, Creutzberg CL, van de Poll-Franse LV, Radisic VB, Galalae R, Schmalz C, Barlow E, Jensen PT, Waldenström AC, Bergmark K, Chie WC, Kuljanic K, Costantini A, Singer S, Koensgen D, Menon U, Daghofer F: Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). Eur J Cancer 2011, 47:183-190.
• [24]Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, Holzner B, Kuljanic K, Lebrec J, D'haese S: EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer 2003, 39:1402-1408.
• [25]Bredart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK: An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer 2005, 41:2120-2131.
• [26]Broadbent E, Petrie KJ, Main J, Weinman J: The brief illness perception questionnaire. J Psychosom Res 2006, 60:631-637.
• [27]Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN: The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum 2003, 49:156-163.
• [28]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370.
• [29]Michielsen HJ, de Vries J, van Heck GL: Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale. J Psychosom Res 2003, 54:345-352.
• [30]Denollet J: DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med 2005, 67:89-97.
• [31]van de Poll-Franse LV, Mols F, Essink-Bot ML, Haartsen JE, Vingerhoets AJ, Lybeert ML, van den Berg HA, Coebergh JW: Impact of external beam adjuvant radiotherapy on health-related quality of life for long-term survivors of endometrial adenocarcinoma: a population-based study. Int J Radiation Oncology Biol Phys 2007, 69:125-132.
• [32]Korfage IJ, Essink-Bot M-L, Mols F, van de Poll-Franse LV, Kruitwagen RFPM, van Ballegooijen M: Health- related quality of life in cervical cancer survivors: a population- based study. Int J Radiation Oncology Biol Phys 2009, 7(3):1501-1509.
• [33]Thong MSY, Mols F, Lemmens VEPP, Rutten HJT, Roukema JA, Martijn H, van de Poll-Franse LV: Impact of preoperative radiotherapy on general and disease-specific health status of rectal cancer survivors: a population based study. Int J Radiation Oncology Biol Phys 2011, in press.
• [34]Husson O, Holterhues C, Mols F, Nijsten T, van de Poll-Franse LV: Melanoma survivors are dissatisfied with perceived information about their diagnosis, treatment and follow-up care. British Journal of Dermatology 2010, 163:879-881.
• [35]Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41:582-592.
• [36]Hox J: Multilevel Analysis: Techniques and Applications. New York: Routledge; 2010.
• [37]Twisk JWR: Applied Multilevel Analysis. A Practical Guide. Cambridge: Cambridge University Press; 2006.
• [38]Twisk JWR: Applied longitudinal data analysis for epidemiology. A practical guide. Cambridge: Cambridge University Press; 2003.