A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
研究概览
简要总结
This is a randomized controlled trial to assess the feasibility and preliminary efficacy of a multicomponent technology-supported care delivery intervention trial in 110 older patients with hematologic malignancies [acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma (MM), and diffuse large b-cell lymphoma (DLBCL)] receiving outpatient chemotherapy on treatment-related toxicities, patient-reported outcomes, healthcare utilization, and inflammatory and epigenetic markers.
详细描述
Compared to younger adults, older adults with cancer are more likely to have age-related vulnerabilities such as functional impairment and co-existing medical conditions. They are also often on many medications. As a result, older adults are more likely to experience treatment-related toxicities. These toxicities can lead to increased healthcare utilization (e.g., hospitalization, emergency room visits), decreased quality of life and functional status, and reduced survival. In addition, a disproportionate number of older adults live in rural areas which often limit access to healthcare. Therefore, there is a need to better support older adults with hematologic malignancies during the course of their treatment to decrease treatment-related toxicities so they can continue to receive treatment. The proposed study will investigate whether digital health technologies can support older adults in various aspects of their cancer care.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Have a new diagnosis of AML, MDS, MM, and DLBCL
- •Have a plan to receive outpatient chemotherapy for at least 4 months (patients may enroll within the first 2 weeks of chemotherapy initiation if they do not have grade 2 or higher non-hematologic adverse event)
- •No plan to or unlikely to proceed with autologous or allogeneic hematopoietic stem cell transplantation (SCT) in the following 5 months (if SCT is planned after 4 cycles of chemotherapy in the case of MDS or myeloma, patients are allowed to enroll)
- •English speaking
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •No medical contraindications for exercise per oncologist
- •Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without the assistive device)
- •Able to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
M-Tech
M-Tech involves the use of a mobile app delivery platform to several interventions. The components of M-Tech include: 1) Hybrid in-person and telehealth visits with oncology providers; 2) Disease-specific education videos; 3) Activity level monitoring via a wearable device with promotion of physical activity; 4) Symptom monitoring with provision of self-management strategies, and 5) Medication management.
干预措施: M-Tech (Behavioral)
Usual Care
Participants randomized to the usual care arm will receive standard of care.
干预措施: Usual Care (Other)
结局指标
主要结局
Difference between experimental and active comparator arms - Clinician-rated non-hematologic treatment-related toxicity
时间窗: 4-5 months
Measured using the Common Terminology Criteria for Adverse Events or CTCAE v5.0 and operationalized based on proportion of patients with grade 3-5 non-hematologic treatment-related toxicity for AML, MDS, and DLBCL or grade 2-5 non-hematologic treatment-related toxicity for MM
Retention rates
时间窗: 4-5 months
Percentage of patients/caregivers who completed baseline assessments and subsequently completed post-intervention assessments
次要结局
- Difference between experimental and active comparator arms - Healthcare Utilization(4-5 months)
- Difference between experimental and active comparator arms - Functional Status(4-5 months)
- Difference between experimental and active comparator arms - Quality of Life(4-5 months)
- Difference between experimental and active comparator arms - Patient-reported treatment-related toxicity(4-5 months)
研究者
Kah Poh Loh
Assistant Professor
University of Rochester