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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Adult patients (aged 18 years or older) with one of the following diagnoses:

1. newly diagnosed multiple myeloma receiving first-line therapy,
2. multiple myeloma on maintenance therapy, or
3. 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

Additional Trial Information

Pilot Trial

Enrollment: 120 patients (estimated)

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Trial Locations

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Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting
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