Brief Title
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers
Official Title
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers. A Pragmatic Cluster Randomized Controlled Trial
Brief Summary
Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer
survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical
or psychosocial effects of cancer and its treatment. There is increasing recognition to
improve information disclosure and cancer survivorship care. The American Institute of
Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors
receive a summary of their course of treatment as a formal document, that also includes
recommendations for subsequent cancer surveillance, management of late effects, and
strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence
exists concerning the positive and negative effects of the implementation of the SCP in daily
clinical practice. The purpose of this study is to assess the impact of SCP care in routine
clinical practice on cancer survivors' satisfaction with information disclosure and care,
quality of life, illness perception, and health care use.
Study Type
Interventional
Primary Outcome
Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, right after initial treatment
Secondary Outcome
Patients' frequency and reason (cancer-related or not) for contact with their general practitioner or medical specialist in the past 12 months, measuring 'Patients' health care use', right after initial treatment
Condition
Ovarian Cancer
Intervention
SCP care
Study Arms / Comparison Groups
Usual care
Description: The gynaecological oncologist (GO) provides care as usual. Currently, hospitals provide follow-up following the Dutch guidelines, meaning that they see their patients on given time points based on the number of years after diagnosis. Most hospitals give their patients leaflets regarding the diagnosis and treatment they receive, however none of them provide personalized information. All information is given during the initial treatment phase, but none of the GOs give additional information during follow-up. None of the GOs is actively screening on psychosocial needs. As this might change in time, we will ask the providers and patients about the type of information they provide, respectively, receive.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
396
Start Date
April 2011
Completion Date
July 2016
Primary Completion Date
July 2016
Eligibility Criteria
Inclusion Criteria:
- Women who are newly diagnosed with endometrial or ovarian cancer in one of the 12
participating hospitals.
- The patients have to be able to complete a Dutch questionnaire.
Exclusion Criteria:
- Patients who are not able to read or write Dutch will be excluded, as they are not
able to complete a Dutch questionnaire.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lonneke V van de Poll-Franse, Dr. Prof., ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT01185626
Organization ID
UVT 2010-4743
Responsible Party
Sponsor-Investigator
Study Sponsor
Lonneke van de Poll-Franse
Collaborators
Comprehensive Cancer Centre The Netherlands
Study Sponsor
Lonneke V van de Poll-Franse, Dr. Prof., Principal Investigator, Tilburg University, The Netherlands
Verification Date
May 2017