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

Volumn 12, Issue , 2011, Pages

  van de Poll Franse, Lonneke V ^a,b   Nicolaije, Kim A H ^a,b   Vos, Maria C ^c   Pijnenborg, Johanna M A ^c   Boll, Dorry ^c   Husson, Olga ^a,b   Ezendam, Nicole P M ^a,b   Boss, Erik A ^d   Hermans, Ralph H M ^e   Engelhart, Karin C M ^f   Haartsen, Joke E ^g   Pijlman, Brenda M ^h   Feijen, Harrie W H ⁱ   Mertens, Helena J M M ^j   Nolting, Willem E ^k   van Beek, Johannes J ^l   Roukema, Jan A ^a,c   Kruitwagen, Roy F P M ^m  

^a TILBURG UNIVERSITY   (Netherlands)

^b Eindhoven Cancer Registry   (Netherlands)

^c CPRLab   (Netherlands)

^d MÁXIMA MEDICAL CENTER   (Netherlands)

^e CATHARINA HOSPITAL   (Netherlands)

^f ST ANNA HOSPITAL   (Netherlands)

^g ELKERLIEK HOSPITAL   (Netherlands)

^h JEROEN BOSCH HOSPITAL   (Netherlands)

ⁱ AMPHIA HOSPITAL   (Netherlands)

^j Sittard Geleen Heerlen   (Netherlands)

^k St Jans Hospital   (Netherlands)

^l Department of Gynecology   (Netherlands)

^m MAASTRICHT UNIVERSITY   (Netherlands)

more..

Author keywords

Endometrial cancer; Gynecological cancer survivors; Health care providers; Health related quality of life; Ovarian cancer; Patient reported outcomes; Pragmatic cluster randomized controlled trial; Satisfaction with care; Satisfaction with information provision; Survivorship care plan

Indexed keywords

ANXIETY; ARTICLE; CANCER DIAGNOSIS; CANCER PATIENT; CANCER STAGING; CANCER SURGERY; CANCER SURVIVOR; CLINICAL PRACTICE; CLINICAL PROTOCOL; COMORBIDITY; CONTROLLED STUDY; DEPRESSION; DYSTHYMIA; ENDOMETRIUM CANCER; FATIGUE; GYNECOLOGIST; HEALTH CARE PERSONNEL; HEALTH CARE UTILIZATION; HUMAN; INFORMATION DISSEMINATION; MEDICAL INFORMATION SYSTEM; MENTAL STRESS; MULTICENTER STUDY; NETHERLANDS; OUTCOME ASSESSMENT; OVARY CANCER; PATIENT CARE; PATIENT CARE PLANNING; PATIENT REFERRAL; PATIENT SATISFACTION; PERCEPTION; PREVALENCE; PROSPECTIVE STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REGISTRATION SYSTEM ONCOLOGICAL GYNECOLOGY; SURVIVORSHIP CARE PLAN; WEB BROWSER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; FEMALE; FEMALE GENITAL TRACT TUMOR; MORTALITY; PSYCHOLOGICAL ASPECT; SAMPLE SIZE; SURVIVAL RATE;

CLINICAL PROTOCOLS; FEMALE; GENITAL NEOPLASMS, FEMALE; HEALTH PERSONNEL; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION; QUALITY OF LIFE; SAMPLE SIZE; SURVIVAL RATE;

EID: 82655183764     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-256     Document Type: Article

References (38)

1. Signaleringscommissie kanker van KWF Kankerbestrijding Kanker in Nederland. Trends, prognoses en implicaties voor zorgvraag 2004, Amsterdam, Signaleringscommissie kanker van KWF Kankerbestrijding.
2. Ayanian JZ, Jacobsen PB. Enhancing research on cancer survivors. J Clin Oncol 2006, 24:5149-5153. 10.1200/JCO.2006.06.7207, 17093278.
3. Gotay CC, Muraoka MY. Quality of life in long-term survivors of adult-onset cancers. J Natl Cancer Inst 1998, 90:656-667. 10.1093/jnci/90.9.656, 9586662.
4. Health Council of the Netherlands Follow-up in oncology. Identify objectives, substantiate actions 2007, The Hague, Health Council of the Netherlands.
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. 10.1002/pon.1305, 18203242.
7. Hesse BW, Arora NK, Burke Beckjord E, Finney Rutten LJ. Information support for cancer survivors. Cancer 2008, 112:2529-2540. 10.1002/cncr.23445, 18428201.
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. 10.1136/bmj.313.7059.724, 2352093, 8819442.
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. 10.1007/s11764-008-0055-0, 18792791.
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. 10.1054/bjoc.2000.1573, 2363610, 11139312.
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. 10.1245/s10434-008-0068-y, 18670823.
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
13. Hewitt M, Greenfield S, Stovall E. From cancer patient to cancer survivor: Lost in transition 2006, Washington, DC.
14. Tan ASL, Bourgoin A, Gray SW, Armstrong K, Hornik RC. How does patient-clinician information engagement influence self-reported cancer-related problems?. Cancer
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. 10.1136/bmj.a2390, 19001484, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups.
16. Campbell MK, Elbourne DR, Altman DG, . for the CONSORT group CONSORT statement: extension to cluster randomized trials. BMJ 2004, 328:702-708. 10.1136/bmj.328.7441.702, 381234, 15031246, for the CONSORT group.
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,
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. 10.1200/JCO.2007.14.2851, 18258984.
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. 10.1002/cncr.23622, 18618581.
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. 10.1002/pon.1047, 16858744.
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. 10.1093/jnci/85.5.365, 8433390.
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. 10.1016/j.ejca.2010.08.014, 20851597.
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. 10.1016/S0959-8049(03)00307-1, 12826043.
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. 10.1016/j.ejca.2005.04.041, 16182120.
26. Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res 2006, 60:631-637. 10.1016/j.jpsychores.2005.10.020, 16731240.
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. 10.1002/art.10993, 12687505.
28. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370. 10.1111/j.1600-0447.1983.tb09716.x, 6880820.
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. 10.1016/S0022-3999(02)00392-6, 12670612.
30. Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med 2005, 67:89-97. 10.1097/01.psy.0000149256.81953.49, 15673629.
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,
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. 10.1111/j.1365-2133.2010.09895.x, 20854404.
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 2010, New York: Routledge.
37. Twisk JWR. Applied Multilevel Analysis. A Practical Guide 2006, Cambridge: Cambridge University Press.
38. Twisk JWR. Applied longitudinal data analysis for epidemiology. A practical guide 2003, Cambridge: Cambridge University Press.