Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of a Psychosocial Mobile Application (THRIVE-M) for Patients Living With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Behavioral: THRIVE-M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - Patients with acute or unstable psychiatric or cognitive conditions that the treating clinicians believe prohibit informed consent or compliance with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THRIVE-M<br>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. | Behavioral: THRIVE-M<br>* THRIVE-M is a self-administered psychosocial mobile application for patients living with multiple myeloma that includes the following five modules: Health module - teaching patients about physical symptoms and strategies to cope with physical symptoms Relationships module - helping patients articulate different support needs and communication styles in navigating relationships emotions module - helping patients identify connections between thoughts, feelings, and behaviors, as well as helpful states of mind and gratitude Lifestyle module - helping patients practice skills for saving up energy and using self-care strategies Reflection module - teaching patients to reflect on their lives, meaningful relationships, and sense of purpose. Each module takes about 15-20 minutes to complete and participants will be instructed to complete all modules within an eight-week period.<br>|
| No Intervention: Usual Care<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life longitudinally based on the FACT-MM scale | Compare quality of life using the Functional Assessment of Cancer therapy (FACT-MM) between the two groups. The FACT-MM ranges 0-164 with higher scores indicating better quality of life. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms. | Up to 15 weeks | 
| Anxiety Symptoms based on the Hospital Anxiety and Depression Scale | Compare anxiety symptoms between participants receiving THRIVE-M versus usual care as measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale. The HADS-Anxiety subscale ranges from 0-21 with higher scores indicating worse anxiety symptoms. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms. | Up to 15 weeks | 
| Depression Symptoms based on the Hospital Anxiety and Depression Scale | Compare depression symptoms between participants receiving THRIVE-M versus usual care as measured by the Hospital Anxiety and Depression Scale (HADS)-depression. The HADS-Depression subscale ranges from 0-21 with higher scores indicating worse depression symptoms. Higher scores on the HADS-depression subscale (range 0-21) indicate greater depression symptoms. | Up to 15 weeks | 
| Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist | Compare PTSD symptoms between participants receiving THRIVE-M versus usual care as measured by the PTSD Checklist-Civilian Version. The PTSD checklist score ranges from 17-85 with higher scores indicating worse post-traumatic stress symptoms. Higher Scores on the PTSD Checklist-Civilian Version (range 17-85) indicate greater PTSD symptoms. | Up to 15 weeks | 
| Fatigue based on the FACT-Fatigue Scale | Compare fatigue between participants receiving THRIVE-M versus usual care as measured by the Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue). The FACT-Fatigue ranges from 0-52 with higher scores indicating lower fatigue. Higher scores on the FACT-Fatigue (range 0-52) indicate worse fatigue. | Up to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma