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临床试验/NCT04730505
NCT04730505终止1 期

A Multi-center, Randomized, Pilot Trial to Evaluate the My Hematology Oncology Patient Experience (MYHOPE™) for Multiple Myeloma (MM) Digital Care Network in Patients With MM

Celgene34 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年2月4日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
发起方
Celgene
入组人数
2
试验地点
34
主要终点
Monthly eligibility and recruitment rates per month of patients with multiple myeloma

研究概览

简要总结

NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
  • •Patient must reside in the USA.
  • •Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:
  • •Newly-diagnosed multiple myeloma transplant-eligible
  • •Patients undergoing their first ASCT
  • •Newly-diagnosed multiple myeloma transplant-ineligible
  • •Relapsed and/or refractory.

排除标准

  • •Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
  • •Patient is on hospice.
  • •Patient is receiving or has received an investigational agent < 28 days prior to randomization or during this pilot study.

研究组 & 干预措施

Patient App + HCP Portal (Cohort 1)

Experimental

Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal

干预措施: MyHOPE™ for Multiple Myeloma (Device)

Patient App + HCP Portal (Cohort 1)

Experimental

Cohort 1 is to assess how patients will use the Patient App if connected in real time with the Healthcare professional (HCP) Portal

干预措施: MyHope HCP Portal (Device)

Patient App Alone (Cohort 2)

Experimental

Cohort 2 is to assess how patients will use the Patient App where there is no connectivity to the Healthcare professional (HCP) Portal and thus no real-time data sharing with the HCP Portal

干预措施: MyHOPE™ for Multiple Myeloma (Device)

结局指标

主要结局

Monthly eligibility and recruitment rates per month of patients with multiple myeloma

时间窗: Up to 12 months

is defined as the number of patients with MM that satisfied entry criteria per study site/month)

Duration of follow-up

时间窗: Up to 6 months

is defined as the mean, median, and range of time from each user's first login to his or her last login to the Patient App or to the HCP Portal

Frequency of user access by feature and by month, relative to the enrollment date of each participant

时间窗: Up to 6 months

Is defined as how often patients access various features of the app, per month relative to the enrollment date of each participant

Patient empowerment and self-efficacy measured by CASE-Cancer

时间窗: Up to 6 months

The instrument consists of 3 subscales: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. All items are scored on a range of 1 to 4 from strongly disagree to strongly agree, with higher score indicating better empowerment

User average weekly log-in rates over the duration of follow-up from patients with MM and HCPs

时间窗: Up to 6 months

is defined as the number of times a user attempts to log in/week

Patient-reported outcome completion rates

时间窗: Up to 6 months

Is defined as the number of data points that are completed divided by the number of data points that could have been completed at each specified timepoint, relative to the enrollment date of each participant

Percentage of patients for whom the HCPs complete the 6-month assessments

时间窗: up to 18 months

is defined as number of patients for whom HCPs provided 6-month assessments \[eg, disease response assessments\] divided by the number of patients for whom HCPs provided baseline data)

次要结局

  • Proportion of respondents scoring 4 or 5 on the Patient Platform Usability Survey or Healthcare Provider Platform Survey(Up to 18 months)
  • Quality of life measured by Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score(Up to 6 months)

研究者

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (34)

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