NCT01185626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable ovarian-cancer

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

5.3 years

First QC Date

August 17, 2010

Last Update Submit

May 8, 2017

Conditions

Ovarian CancerEndometrium Cancer

Keywords

patients

Outcome Measures

Primary Outcomes (20)

  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, right after initial treatment

    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.

    Right after initial treatment (t0)

  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, right after initial treatment

    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).

    Right after initial treatment (t0)

  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, right after initial treatment

    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.

    Right after initial treatment (t0)

  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, right after initial treatment

    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.

    Right after initial treatment (t0)

  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 6 months after initial treatment

    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.

    6 months after initial treatment (t1)

  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 6 months after initial treatment

    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).

    6 months after initial treatment (t1)

  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 6 months after initial treatment

    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.

    6 months after initial treatment (t1)

  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 6 months after initial treatment

    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.

    6 months after initial treatment (t1)

  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 12 months after initial treatment

    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.

    12 months after initial treatment (t2)

  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 12 months after initial treatment

    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).

    12 months after initial treatment (t2)

  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 12 months after initial treatment

    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.

    12 months after initial treatment (t2)

  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 12 months after initial treatment

    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.

    12 months after initial treatment (t2)

  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 18 months after initial treatment

    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.

    18 months after initial treatment (t3)

  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 18 months after initial treatment

    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).

    18 months after initial treatment (t3)

  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 18 months after initial treatment

    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.

    18 months after initial treatment (t3)

  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 18 months after initial treatment

    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.

    18 months after initial treatment (t3)

  • Patients' score on the EORTC-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, 24 months after initial treatment

    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.

    24 months after initial treatment (t4)

  • Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 24 months after initial treatment

    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).

    24 months after initial treatment (t4)

  • Patients' score on the EORTC IN-PATSAT3216 questionnaire, measuring ´Satisfaction with care´, 24 months after initial treatment

    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.

    24 months after initial treatment (t4)

  • Patients' score on the Brief Illness Perception Questionnaire (B-IPQ)21, measuring ´Illness perception´, 24 months after initial treatment

    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.

    24 months after initial treatment (t4)

Secondary Outcomes (7)

  • 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

    Right after initial treatment (t0)

  • Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP

    At the start of the study (t0)

  • Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP

    At the end of the study (t5)

  • 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

    6 months after initial treatment (t1)

  • 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

    12 months after initial treatment (t2)

  • +2 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

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.

SCP care

EXPERIMENTAL

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

Interventions

SCP careOTHER
SCP care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 RW, Netherlands

Location

Amphia Ziekenhuis

Breda, 4818 CK & 4901 DH, Netherlands

Location

Catharina-Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, 5631 BM & 5504 DB, Netherlands

Location

St. Anna Ziekenhuis

Geldrop, 5664 EH & 5644 RX, Netherlands

Location

Elkerliek Ziekenhuis

Helmond, 5707 HA, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, 6202 AZ, Netherlands

Location

Orbis Medisch Centrum

Sittard, Netherlands

Location

St. Elisabeth Hospital

Tilburg, 5022 GC, Netherlands

Location

TweeSteden Ziekenhuis

Tilburg, 5042 AD & 5141 BM, Netherlands

Location

VieCuri Medisch Centrum

Venlo, 5912 BL & 5801 CE, Netherlands

Location

St. Jans Gasthuis

Weert, Netherlands

Location

Related Publications (10)

  • 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.

    PMID: 22141750BACKGROUND

  • 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.

    PMID: 26304900RESULT

  • 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.

    PMID: 24866923RESULT

  • 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.

    PMID: 24357226RESULT

  • 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.

    PMID: 27392550RESULT

  • 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.

    PMID: 27480883RESULT

  • 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.

    PMID: 28279480RESULT

  • 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.

    PMID: 28283195RESULT

  • 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.

    PMID: 34453569DERIVED

  • 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.

    PMID: 29511906DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • Lonneke V van de Poll-Franse, Dr. Prof.

    Tilburg University, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Nicole PM Ezendam, Dr.

    The Netherlands Comprehensive Cancer Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Prof.

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 20, 2010

Study Start

April 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

NL(12)