Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 99
- 试验地点
- 40
- 主要终点
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1
研究概览
简要总结
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group).
Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (≥ 20 years of age)
- •Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
- •Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
- •Initiating first or second line treatment at study entry with one of the following therapies:
- •palbociclib plus endocrine therapy or endocrine monotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status = 0~
- •Owns or has regular access to an Apple iPhone or Android phone.
- •Willing and able to complete collection of data via smartphone-based application.
- •Willing and able to wear the wearable device for approximately 6 months.
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •Able to read and understand Japanese
排除标准
- •The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
- •The patient is on active treatment for other malignancies other than ABC.
- •The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion
结局指标
主要结局
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1
时间窗: Baseline, Cycle 1 (1 cycle = 4 Weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2
时间窗: Baseline, Cycle 2 (1 cycle = 4 weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3
时间窗: Baseline, Cycle 3 (1 cycle = 4 Weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4
时间窗: Baseline, Cycle 4 (1 cycle = 4 Weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5
时间窗: Baseline, Cycle 5 (1 cycle = 4 Weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6
时间窗: Baseline, Cycle 6 (1 cycle = 4 Weeks)
The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.
Change From Baseline in Sedentary Time Wearing at Week 1
时间窗: Baseline, Week 1
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 2
时间窗: Baseline, Week 2
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 3
时间窗: Baseline, Week 3
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 4
时间窗: Baseline, Week 4
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 5
时间窗: Baseline, Week 5
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 6
时间窗: Baseline, Week 6
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 7
时间窗: Baseline, Week 7
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 8
时间窗: Baseline, Week 8
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 9
时间窗: Baseline, Week 9
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 10
时间窗: Baseline, Week 10
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 11
时间窗: Baseline, Week 11
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 12
时间窗: Baseline, Week 12
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 13
时间窗: Baseline, Week 13
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 14
时间窗: Baseline, Week 14
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 15
时间窗: Baseline, Week 15
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 16
时间窗: Baseline, Week 16
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 17
时间窗: Baseline, Week 17
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 18
时间窗: Baseline, Week 18
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 19
时间窗: Baseline, Week 19
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 20
时间窗: Baseline, Week 20
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 21
时间窗: Baseline, Week 21
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 22
时间窗: Baseline, Week 22
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 23
时间窗: Baseline, Week 23
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
Change From Baseline in Sedentary Time Wearing at Week 24
时间窗: Baseline, Week 24
Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.
次要结局
- Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events(From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks))
- Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Number of Participants According to Fatigue Interference Based on PRO-CTCAE(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Number of Participants According to Pain Severity Based on PRO-CTCAE(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Number of Participants According to Pain Interference Based on PRO-CTCAE(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Number of Participants According to Pain Frequency Based on PRO-CTCAE(Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks))
- Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled(Before and after disease progression during the observation period (maximum up to 24 weeks))
- Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled(Before and after disease progression during the observation period (maximum up to 24 weeks))
- MVPA Before and After Disease Progression: Group 1 and 2 Pooled(Before and after disease progression during the observation period (maximum up to 24 weeks))
- EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled(Before and after disease progression during the observation period (maximum up to 24 weeks))
- Number of Participants With Treatment Satisfaction(Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks))
- Number of Participants According to Starting Dose of Palbociclib Treatment(Baseline)
- Number of Participants Who Had Any Palbociclib Dose Reduction(Up to 24 Weeks)
- Number of Participants Who Had Any Palbociclib Dose Interruption(Up to 24 Weeks)
- Number of Participants With Cycle Delay in Palbociclib Treatment(Up to 24 Weeks)