Randomized Controlled Trial of a Psychosocial Mobile Application (THRIVE-M) for Patients Living With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale
研究概览
简要总结
This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care.
详细描述
Multiple myeloma, the second most common hematologic malignancy, can be associated with severe end-organ destruction and life-threatening complications (e.g., kidney failure, infection, anemia) resulting in significant morbidity (e.g., pain syndromes, fatigue). The protracted course and treatment of multiple myeloma is also characterized by physical symptoms that can undermine psychological well-being, functioning, and quality of life across the illness trajectory and care continuum.
Despite the high psychological burden that may accompany life with multiple myeloma, the special mental health workforce needed to adequately address their psychological needs is limited. Hence, mobile application-delivered psychosocial interventions offer an innovative approach to overcome the shortage of psychosocial services to support the unique needs of patients living with multiple myeloma. With no psychosocial mobile application interventions for patients living with multiple myeloma, we developed a patient-centered, population-specific, mobile-application psychosocial intervention, THRIVE-M, tailored to the unique needs of patients living with multiple myeloma. With this study, we will establish the impact of THRIVE-M on patient-reported outcomes compared to usual care.
The study will use validated questionnaires to measure patients' quality of life, psychological distress symptoms, fatigue, and self-management targets like coping, spiritual well-being, and self-efficacy. Study questionnaires will be completed in the hospital or clinic, with an option to also complete them remotely via a secure web link or a mailed paper copy.
Divine Mercy University is funding this research study.
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 (Outcomes Assessor)
盲法说明
This is a double-blind single-site randomized efficacy trial of the THRIVE-M App in 120 patients with multiple myeloma. Patients will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to assign each participant to either THRIVE-M versus usual care.
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
- •Adult patients (aged 18 years or older) with one of the following diagnoses:
- •newly diagnosed multiple myeloma receiving first-line therapy,
- •multiple myeloma on maintenance therapy, or
- •relapsed multiple myeloma receiving 2nd or 3rd line therapy
- •Ability to comprehend, read, and respond to questions in English
排除标准
- •- Patients with acute or unstable psychiatric or cognitive conditions that the treating clinicians believe prohibit informed consent or compliance with study procedures
研究组 & 干预措施
Usual Care
Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care.
Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days.
Participants in the usual care arm will receive their usual care with the multiple myeloma team, including all routine supportive care resources (e.g., support from social work, psychology, or psychiatry) offered by the multiple myeloma team to all patients diagnosed with multiple myeloma.
Patients in both the usual care and THRIVE-M group are permitted to use all supportive care services per usual care. We will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).
THRIVE-M
Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care.
Participants will use THRIVE-M following a diagnosis of multiple myeloma to learn how to cope with physical symptoms, articulate their needs and navigate relationships, and focus on self-care while living with multiple myeloma using an iPad provided by the study team or the participant's own iPad.
Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days.
干预措施: THRIVE-M (Behavioral)
结局指标
主要结局
Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale
时间窗: 8 weeks
Compare quality of life between participants receiving THRIVE-M versus usual care as measured by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) at 8 weeks. the FACT-MM score ranges 0-164 with higher scores indicating better quality of life Higher scores on the FACT-MM (range 0-164) indicate better quality of life.
次要结局
- Depression Symptoms based on the Hospital Anxiety and Depression Scale(Up to 15 weeks)
- Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist(Up to 15 weeks)
- Quality of life longitudinally based on the FACT-MM scale(Up to 15 weeks)
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale(Up to 15 weeks)
- Fatigue based on the FACT-Fatigue Scale(Up to 15 weeks)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital