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

Ovarian Cancer Clinical Trial

— ROGYcare  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185626
• Other study ID #: UVT 2010-4743
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: May 8, 2017
• Start date: April 2011
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer
• Ovarian Cancer

Intervention

Other:
• SCP care

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Catharina-Ziekenhuis	Eindhoven
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	St. Anna Ziekenhuis	Geldrop
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Orbis Medisch Centrum	Sittard
Netherlands	St. Elisabeth Hospital	Tilburg
Netherlands	TweeSteden Ziekenhuis	Tilburg
Netherlands	VieCuri Medisch Centrum	Venlo
Netherlands	St. Jans Gasthuis	Weert

Sponsors (3)

Lead Sponsor	Collaborator
Lonneke van de Poll-Franse	Dutch Cancer Society, IKNL

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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; — View 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 — View 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 S — View 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 Registrat — View 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 Au — View 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. 2 — View 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 Ma — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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	Patients will also be asked whether they have been referred to other health care services.	Right after initial treatment (t0)
Secondary	Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP	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.	At the start of the study (t0)
Secondary	Health care providers' score on a questionnaire assessing their evaluation of the (implementation of the) SCP	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.	At the end of the study (t5)
Secondary	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	Patients will also be asked whether they have been referred to other health care services.	6 months after initial treatment (t1)
Secondary	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	Patients will also be asked whether they have been referred to other health care services.	12 months after initial treatment (t2)
Secondary	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	Patients will also be asked whether they have been referred to other health care services.	18 months after initial treatment (t3)
Secondary	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	Patients will also be asked whether they have been referred to other health care services.	24 months after initial treatment (t4)