title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Trial Registration: http://www.ClinicalTrials.gov. Identifier: NCT01185626 Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743.
authors.affiliation: CoRPS - Center of Research on Psychology in Somatic Diseases, Department of Medical Psychology, Tilburg University, Tilburg, The Netherlands. l.vd.poll@uvt.nl
authors.forename: Lonneke V
authors.initials: LV
authors.lastname: van de Poll-Franse
authors.forename: Kim A H
authors.initials: KA
authors.lastname: Nicolaije
authors.forename: Maria C
authors.initials: MC
authors.lastname: Vos
authors.forename: Johanna M A
authors.initials: JM
authors.lastname: Pijnenborg
authors.forename: Dorry
authors.initials: D
authors.lastname: Boll
authors.forename: Olga
authors.initials: O
authors.lastname: Husson
authors.forename: Nicole P M
authors.initials: NP
authors.lastname: Ezendam
authors.forename: Erik A
authors.initials: EA
authors.lastname: Boss
authors.forename: Ralph H M
authors.initials: RH
authors.lastname: Hermans
authors.forename: Karin C M
authors.initials: KC
authors.lastname: Engelhart
authors.forename: Joke E
authors.initials: JE
authors.lastname: Haartsen
authors.forename: Brenda M
authors.initials: BM
authors.lastname: Pijlman
authors.forename: Harrie W H
authors.initials: HW
authors.lastname: Feijen
authors.forename: Helena J M M
authors.initials: HJ
authors.lastname: Mertens
authors.forename: Willem E
authors.initials: WE
authors.lastname: Nolting
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: van Beek
authors.forename: Jan A
authors.initials: JA
authors.lastname: Roukema
authors.forename: Roy F P M
authors.initials: RF
authors.lastname: Kruitwagen
mesh_terms: D002985:Clinical Protocols; D005260:Female; D005833:Genital Neoplasms, Female / Q000401:mortality* / Q000523:psychology; D006282:Health Personnel; D006801:Humans; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011788:Quality of Life; D018401:Sample Size; D015996:Survival Rate