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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
  Purpose

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.


Condition Intervention
Ovarian Cancer
Endometrium Cancer
Other: SCP care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: SCP care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185626

Contacts
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

Locations
Netherlands
Jeroen Bosch Ziekenhuis Recruiting
's-Hertogenbosch, Netherlands, 5211 RW
Amphia Ziekenhuis Recruiting
Breda & Oosterhout, Netherlands, 4818 CK & 4901 DH
Catharina-Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
Maxima Medisch Centrum Recruiting
Eindhoven & Veldhoven, Netherlands, 5631 BM & 5504 DB
St. Anna Ziekenhuis Recruiting
Geldrop & Eindhoven, Netherlands, 5664 EH & 5644 RX
Elkerliek Ziekenhuis Recruiting
Helmond, Netherlands, 5707 HA
Maastricht Universitair Medisch Centrum Recruiting
Maastricht, Netherlands, 6202 AZ
Orbis Medisch Centrum Recruiting
Sittard, Netherlands
St. Elisabeth Hospital Recruiting
Tilburg, Netherlands, 5022 GC
Contact: Caroline Vos, Drs    +31-13-5391313    C.Vos@Elisabeth.nl   
TweeSteden Ziekenhuis Recruiting
Tilburg & Waalwijk, Netherlands, 5042 AD & 5141 BM
VieCuri Medisch Centrum Recruiting
Venlo & Venray, Netherlands, 5912 BL & 5801 CE
St. Jans Gasthuis Recruiting
Weert, Netherlands
Sponsors and Collaborators
Lonneke van de Poll-Franse
Comprehensive Cancer Centre South (CCCS)
Dutch Cancer Society
Investigators
Principal Investigator: Lonneke V van de Poll-Franse, Dr Tilburg University, The Netherlands
  More Information

No publications provided by University of Tilburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lonneke van de Poll-Franse, Dr., University of Tilburg
ClinicalTrials.gov Identifier: NCT01185626     History of Changes
Other Study ID Numbers: UVT 2010-4743
Study First Received: August 17, 2010
Last Updated: August 24, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University of Tilburg:
patients

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014