ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers. A Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 22
- 主要终点
- Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 6 months after initial treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
结局指标
主要结局
Patients' score on the EORTC QLQ-C3017 questionnaire, measuring ´Health related quality of life (HRQL)´, 6 months after initial treatment
时间窗: 6 months after initial treatment (t1)
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
时间窗: 6 months after initial treatment (t1)
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
时间窗: 6 months after initial treatment (t1)
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
时间窗: 12 months after initial treatment (t2)
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-INFO26 module15 questionnaire, measuring ´Satisfaction with information provision´, right after initial treatment
时间窗: Right after initial treatment (t0)
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
时间窗: Right after initial treatment (t0)
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
时间窗: Right after initial treatment (t0)
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
时间窗: Right after initial treatment (t0)
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
时间窗: 6 months after initial treatment (t1)
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
时间窗: 12 months after initial treatment (t2)
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
时间窗: 12 months after initial treatment (t2)
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
时间窗: 12 months after initial treatment (t2)
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
时间窗: 18 months after initial treatment (t3)
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
时间窗: 18 months after initial treatment (t3)
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
时间窗: 18 months after initial treatment (t3)
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
时间窗: 18 months after initial treatment (t3)
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
时间窗: 24 months after initial treatment (t4)
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
时间窗: 24 months after initial treatment (t4)
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
时间窗: 24 months after initial treatment (t4)
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
时间窗: 24 months after initial treatment (t4)
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.
次要结局
- 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 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))
- 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(18 months after initial treatment (t3))
- 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(24 months after initial treatment (t4))
研究者
Lonneke van de Poll-Franse
Dr. Prof.
Tilburg University