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ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Tilburg.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Comprehensive Cancer Centre South (CCCS)
Dutch Cancer Society
Information provided by (Responsible Party):
Lonneke van de Poll-Franse, University of Tilburg
ClinicalTrials.gov Identifier:
NCT01185626
First received: August 17, 2010
Last updated: August 24, 2011
Last verified: August 2011

August 17, 2010
August 24, 2011
April 2011
April 2014   (final data collection date for primary outcome measure)
  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, right after initial treatment [ Time Frame: Right after initial treatment (t0) ] [ Designated as safety issue: No ]
    Evaluating satisfaction with information on different areas of the disease, diagnosis, treatment and care. It contains the following scales: (a) Information about the disease; (b) Information about medical tests; (c) Information about treatment; (d) Information on other services, and single items: (a) Written information; (b) Information on CDs or tape/video; (c) Satisfaction with the amount of information; (d) Desire for more information; (e) Desire for less information; (f) Helpfulness of information.
  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, right after initial treatment [ Time Frame: Right after initial treatment (t0) ] [ Designated as safety issue: No ]
    Measuring cancer specific HRQL, including scales assessing physical, role, cognitive and emotional functioning, fatigue and sleep problems, and overall health and quality of life.This core instrument is supplemented by a condition-specific questionnaire module (for ovarian cancer: EORTC-OV module18, for endometrial cancer: EORTC-EN module).
  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, right after initial treatment [ Time Frame: Right after initial treatment (t0) ] [ Designated as safety issue: No ]
    Assessing patients' perception of quality of medical care, nursing care and care organization and hospital services . It contains 11 multi-item and 3 single-item scales, including doctors' and nurses' skills, information provision, and availability.
  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, right after initial treatment [ Time Frame: Right after initial treatment (t0) ] [ Designated as safety issue: No ]
    The scale has 9 items, measuring (a) cognitive representations (consequences, timeline, personal control, treatment control, identity); (b) emotional representations (concern, emotion); (c) illness comprehensibility; and (d) an open-ended response item on the 3 most important causal factors of illness.
  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 6 months after initial treatment [ Time Frame: 6 months after initial treatment (t1) ] [ Designated as safety issue: No ]
    Evaluating satisfaction with information on different areas of the disease, diagnosis, treatment and care. It contains the following scales: (a) Information about the disease; (b) Information about medical tests; (c) Information about treatment; (d) Information on other services, and single items: (a) Written information; (b) Information on CDs or tape/video; (c) Satisfaction with the amount of information; (d) Desire for more information; (e) Desire for less information; (f) Helpfulness of information.
  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 6 months after initial treatment [ Time Frame: 6 months after initial treatment (t1) ] [ Designated as safety issue: No ]
    Measuring cancer specific HRQL, including scales assessing physical, role, cognitive and emotional functioning, fatigue and sleep problems, and overall health and quality of life.This core instrument is supplemented by a condition-specific questionnaire module (for ovarian cancer: EORTC-OV module18, for endometrial cancer: EORTC-EN module).
  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 6 months after initial treatment [ Time Frame: 6 months after initial treatment (t1) ] [ Designated as safety issue: No ]
    Assessing patients' perception of quality of medical care, nursing care and care organization and hospital services . It contains 11 multi-item and 3 single-item scales, including doctors' and nurses' skills, information provision, and availability.
  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 6 months after initial treatment [ Time Frame: 6 months after initial treatment (t1) ] [ Designated as safety issue: No ]
    The scale has 9 items, measuring (a) cognitive representations (consequences, timeline, personal control, treatment control, identity); (b) emotional representations (concern, emotion); (c) illness comprehensibility; and (d) an open-ended response item on the 3 most important causal factors of illness.
  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 12 months after initial treatment [ Time Frame: 12 months after initial treatment (t2) ] [ Designated as safety issue: No ]
    Evaluating satisfaction with information on different areas of the disease, diagnosis, treatment and care. It contains the following scales: (a) Information about the disease; (b) Information about medical tests; (c) Information about treatment; (d) Information on other services, and single items: (a) Written information; (b) Information on CDs or tape/video; (c) Satisfaction with the amount of information; (d) Desire for more information; (e) Desire for less information; (f) Helpfulness of information.
  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 12 months after initial treatment [ Time Frame: 12 months after initial treatment (t2) ] [ Designated as safety issue: No ]
    Measuring cancer specific HRQL, including scales assessing physical, role, cognitive and emotional functioning, fatigue and sleep problems, and overall health and quality of life.This core instrument is supplemented by a condition-specific questionnaire module (for ovarian cancer: EORTC-OV module18, for endometrial cancer: EORTC-EN module).
  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 12 months after initial treatment [ Time Frame: 12 months after initial treatment (t2) ] [ Designated as safety issue: No ]
    Assessing patients' perception of quality of medical care, nursing care and care organization and hospital services . It contains 11 multi-item and 3 single-item scales, including doctors' and nurses' skills, information provision, and availability.
  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 12 months after initial treatment [ Time Frame: 12 months after initial treatment (t2) ] [ Designated as safety issue: No ]
    The scale has 9 items, measuring (a) cognitive representations (consequences, timeline, personal control, treatment control, identity); (b) emotional representations (concern, emotion); (c) illness comprehensibility; and (d) an open-ended response item on the 3 most important causal factors of illness.
  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 18 months after initial treatment [ Time Frame: 18 months after initial treatment (t3) ] [ Designated as safety issue: No ]
    Evaluating satisfaction with information on different areas of the disease, diagnosis, treatment and care. It contains the following scales: (a) Information about the disease; (b) Information about medical tests; (c) Information about treatment; (d) Information on other services, and single items: (a) Written information; (b) Information on CDs or tape/video; (c) Satisfaction with the amount of information; (d) Desire for more information; (e) Desire for less information; (f) Helpfulness of information.
  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 18 months after initial treatment [ Time Frame: 18 months after initial treatment (t3) ] [ Designated as safety issue: No ]
    Measuring cancer specific HRQL, including scales assessing physical, role, cognitive and emotional functioning, fatigue and sleep problems, and overall health and quality of life.This core instrument is supplemented by a condition-specific questionnaire module (for ovarian cancer: EORTC-OV module18, for endometrial cancer: EORTC-EN module).
  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 18 months after initial treatment [ Time Frame: 18 months after initial treatment (t3) ] [ Designated as safety issue: No ]
    Assessing patients' perception of quality of medical care, nursing care and care organization and hospital services . It contains 11 multi-item and 3 single-item scales, including doctors' and nurses' skills, information provision, and availability.
  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 18 months after initial treatment [ Time Frame: 18 months after initial treatment (t3) ] [ Designated as safety issue: No ]
    The scale has 9 items, measuring (a) cognitive representations (consequences, timeline, personal control, treatment control, identity); (b) emotional representations (concern, emotion); (c) illness comprehensibility; and (d) an open-ended response item on the 3 most important causal factors of illness.
  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 24 months after initial treatment [ Time Frame: 24 months after initial treatment (t4) ] [ Designated as safety issue: No ]
    Evaluating satisfaction with information on different areas of the disease, diagnosis, treatment and care. It contains the following scales: (a) Information about the disease; (b) Information about medical tests; (c) Information about treatment; (d) Information on other services, and single items: (a) Written information; (b) Information on CDs or tape/video; (c) Satisfaction with the amount of information; (d) Desire for more information; (e) Desire for less information; (f) Helpfulness of information.
  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 24 months after initial treatment [ Time Frame: 24 months after initial treatment (t4) ] [ Designated as safety issue: No ]
    Measuring cancer specific HRQL, including scales assessing physical, role, cognitive and emotional functioning, fatigue and sleep problems, and overall health and quality of life.This core instrument is supplemented by a condition-specific questionnaire module (for ovarian cancer: EORTC-OV module18, for endometrial cancer: EORTC-EN module).
  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 24 months after initial treatment [ Time Frame: 24 months after initial treatment (t4) ] [ Designated as safety issue: No ]
    Assessing patients' perception of quality of medical care, nursing care and care organization and hospital services . It contains 11 multi-item and 3 single-item scales, including doctors' and nurses' skills, information provision, and availability.
  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 24 months after initial treatment [ Time Frame: 24 months after initial treatment (t4) ] [ Designated as safety issue: No ]
    The scale has 9 items, measuring (a) cognitive representations (consequences, timeline, personal control, treatment control, identity); (b) emotional representations (concern, emotion); (c) illness comprehensibility; and (d) an open-ended response item on the 3 most important causal factors of illness.
Same as current
Complete list of historical versions of study NCT01185626 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Right after initial treatment (t0) ] [ Designated as safety issue: No ]
    Patients will also be asked whether they have been referred to other health care services.
  • Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP [ Time Frame: At the start of the study (t0) ] [ Designated as safety issue: No ]
    The questionnaire will contain questions regarding how much time the health care providers in general expect to spend on SCP care, and what problems they expect to encounter in daily practice.
  • Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP [ Time Frame: At the end of the study (t5) ] [ Designated as safety issue: No ]
    The questionnaire will contain questions regarding how much time the health care providers spent on SCP care, and what problems they encountered in daily practice.
  • 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 [ Time Frame: 6 months after initial treatment (t1) ] [ Designated as safety issue: No ]
    Patients will also be asked whether they have been referred to other health care services.
  • 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 [ Time Frame: 12 months after initial treatment (t2) ] [ Designated as safety issue: No ]
    Patients will also be asked whether they have been referred to other health care services.
  • 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 [ Time Frame: 18 months after initial treatment (t3) ] [ Designated as safety issue: No ]
    Patients will also be asked whether they have been referred to other health care services.
  • 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 [ Time Frame: 24 months after initial treatment (t4) ] [ Designated as safety issue: No ]
    Patients will also be asked whether they have been referred to other health care services.
Same as current
Not Provided
Not Provided
 
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers. A Pragmatic Cluster Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Ovarian Cancer
  • Endometrium Cancer
Other: SCP care
  • No Intervention: Usual care
    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.
    Intervention: Other: SCP care
  • Experimental: SCP care
    After initial treatment, the GO provides the patient with a paper SCP and takes time to discuss all items in the SCP. Each time during follow-up meetings between patient and GO, the patient will receive an updated SCP if applicable. The paper SCP is extracted from the online registration system 'ROGY' (Registrationsystem Oncological GYnaecology) and combines personal patient and disease data with tailored information that is related to the specific situation of this patient. Recurrences, toxicities or additionally involved specialists will be registered in ROGY and automatically updated in the personal SCP.
    Intervention: Other: SCP care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Kim AH Nicolaije, MSc +31-40-2971616 k.a.h.nicolaije@uvt.nl
Contact: Lonneke V van de Poll-Franse, Dr +31-40-2971616 l.vd.poll@uvt.nl
Netherlands
 
NCT01185626
UVT 2010-4743
Yes
Lonneke van de Poll-Franse, University of Tilburg
Lonneke van de Poll-Franse
  • Comprehensive Cancer Centre South (CCCS)
  • Dutch Cancer Society
Principal Investigator: Lonneke V van de Poll-Franse, Dr Tilburg University, The Netherlands
University of Tilburg
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP