Clinical trial NCT01185626: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Endometrium Cancer
Keywords: patients
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Comprehensive Cancer Centre The Netherlands
name: Dutch Cancer Society
First posted: 2010-08-20
Enrollment: 396
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, right after initial treatment
timeFrame: Right after initial treatment (t0)
measure: Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, right after initial treatment
timeFrame: Right after initial treatment (t0)
measure: Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, right after initial treatment
timeFrame: Right after initial treatment (t0)
measure: Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, right after initial treatment
timeFrame: Right after initial treatment (t0)
measure: Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 6 months after initial treatment
timeFrame: 6 months after initial treatment (t1)
measure: Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 6 months after initial treatment
timeFrame: 6 months after initial treatment (t1)
measure: Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 6 months after initial treatment
timeFrame: 6 months after initial treatment (t1)
measure: Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 6 months after initial treatment
timeFrame: 6 months after initial treatment (t1)
measure: Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 12 months after initial treatment
timeFrame: 12 months after initial treatment (t2)
measure: Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 12 months after initial treatment
timeFrame: 12 months after initial treatment (t2)
measure: Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 12 months after initial treatment
timeFrame: 12 months after initial treatment (t2)
measure: Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 12 months after initial treatment
timeFrame: 12 months after initial treatment (t2)
measure: Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 18 months after initial treatment
timeFrame: 18 months after initial treatment (t3)
measure: Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 18 months after initial treatment
timeFrame: 18 months after initial treatment (t3)
measure: Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 18 months after initial treatment
timeFrame: 18 months after initial treatment (t3)
measure: Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 18 months after initial treatment
timeFrame: 18 months after initial treatment (t3)
measure: Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 24 months after initial treatment
timeFrame: 24 months after initial treatment (t4)
measure: Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 24 months after initial treatment
timeFrame: 24 months after initial treatment (t4)
measure: Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 24 months after initial treatment
timeFrame: 24 months after initial treatment (t4)
measure: Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 24 months after initial treatment
timeFrame: 24 months after initial treatment (t4)
Secondary outcomes:
measure: 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
timeFrame: Right after initial treatment (t0)
measure: Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP
timeFrame: At the start of the study (t0)
measure: Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP
timeFrame: At the end of the study (t5)
measure: 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', 6 months after initial treatment
timeFrame: 6 months after initial treatment (t1)
measure: 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', 12 months after initial treatment
timeFrame: 12 months after initial treatment (t2)
measure: 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', 18 months after initial treatment
timeFrame: 18 months after initial treatment (t3)
measure: 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', 24 months after initial treatment
timeFrame: 24 months after initial treatment (t4)
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina-Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Sittard
country: Netherlands
facility: Orbis Medisch Centrum
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Weert
country: Netherlands
facility: St. Jans Gasthuis
Study officials:
affiliation: Tilburg University, The Netherlands
name: Lonneke V van de Poll-Franse, Dr. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Comprehensive Cancer Organisation
name: Nicole PM Ezendam, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van de Poll-Franse LV, Nicolaije KA, Vos MC, Pijnenborg JM, Boll D, Husson O, Ezendam NP, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, Feijen HW, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Kruitwagen RF. 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. 2011 Dec 5;12:256. doi: 10.1186/1745-6215-12-256.
citation: Nicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, Boll D, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, van Loon-Baelemans IE, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Zijlstra WP, Kruitwagen RF, van de Poll-Franse LV. Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial. J Clin Oncol. 2015 Nov 1;33(31):3550-9. doi: 10.1200/JCO.2014.60.3399. Epub 2015 Aug 24.
citation: Ezendam NP, Nicolaije KA, Kruitwagen RF, Pijnenborg JM, Vos MC, Boll D, van Bommel M, van de Poll-Franse LV. Survivorship Care Plans to inform the primary care physician: results from the ROGY care pragmatic cluster randomized controlled trial. J Cancer Surviv. 2014 Dec;8(4):595-602. doi: 10.1007/s11764-014-0368-0. Epub 2014 May 28.
citation: Nicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, van de Poll-Franse LV, Kruitwagen RF. Oncology providers' evaluation of the use of an automatically generated cancer survivorship care plan: longitudinal results from the ROGY Care trial. J Cancer Surviv. 2014 Jun;8(2):248-59. doi: 10.1007/s11764-013-0327-1. Epub 2013 Dec 20.
citation: Nicolaije KA, Ezendam NP, Pijnenborg JM, Boll D, Vos MC, Kruitwagen RF, van de Poll-Franse LV. Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial. J Med Internet Res. 2016 Jul 8;18(7):e162. doi: 10.2196/jmir.4914.
citation: de Rooij BH, Ezendam NP, Nicolaije KA, Vos MC, Pijnenborg JM, Boll D, Kruitwagen RF, van de Poll-Franse LV. Factors influencing implementation of a survivorship care plan-a quantitative process evaluation of the ROGY Care trial. J Cancer Surviv. 2017 Feb;11(1):64-73. doi: 10.1007/s11764-016-0562-3. Epub 2016 Aug 1.
citation: van Broekhoven MECL, de Rooij BH, Pijnenborg JMA, Vos MC, Boll D, Kruitwagen RFPM, van de Poll-Franse LV, Ezendam NPM. Illness perceptions and changes in lifestyle following a gynecological cancer diagnosis: A longitudinal analysis. Gynecol Oncol. 2017 May;145(2):310-318. doi: 10.1016/j.ygyno.2017.02.037. Epub 2017 Mar 6.
citation: de Rooij BH, Ezendam NPM, Nicolaije KAH, Caroline Vos M, Pijnenborg JMA, Boll D, Boss EA, Hermans RHM, Engelhart KCM, Haartsen JE, Pijlman BM, van Loon-Baelemans IEAM, Mertens HJMM, Nolting WE, van Beek JJ, Roukema JA, Kruitwagen RFPM, van de Poll-Franse LV. Effects of Survivorship Care Plans on patient reported outcomes in ovarian cancer during 2-year follow-up - The ROGY care trial. Gynecol Oncol. 2017 May;145(2):319-328. doi: 10.1016/j.ygyno.2017.02.041. Epub 2017 Mar 7.
citation: Driessen KAJ, de Rooij BH, Vos MC, Boll D, Pijnenborg JMA, Hoedjes M, Beijer S, Ezendam NPM. Cancer-related psychosocial factors and self-reported changes in lifestyle among gynecological cancer survivors: cross-sectional analysis of PROFILES registry data. Support Care Cancer. 2022 Feb;30(2):1199-1207. doi: 10.1007/s00520-021-06433-0. Epub 2021 Aug 28.
citation: de Rooij BH, Ezendam NPM, Nicolaije KAH, Lodder P, Vos MC, Pijnenborg JMA, Boll D, Kruitwagen RFPM, van de Poll-Franse LV. Survivorship care plans have a negative impact on long-term quality of life and anxiety through more threatening illness perceptions in gynecological cancer patients: the ROGY care trial. Qual Life Res. 2018 Jun;27(6):1533-1544. doi: 10.1007/s11136-018-1825-4. Epub 2018 Mar 6.