This clinical trial aims to evaluate whether a psychosocial mobile application(THRIVE-M), is efficacious for improving quality of life, psychological distress, andfatigue in patients living with multiple myeloma compared to usual care.
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.
Behavioral: THRIVE-M
THRIVE-M is a self-administered psychosocial mobile application for patients living with
multiple myeloma that includes the following five modules:
1. Health module - teaching patients about physical symptoms and strategies to cope
with physical symptoms
2. Relationships module - helping patients articulate different support needs and
communication styles in navigating relationships
3. emotions module - helping patients identify connections between thoughts, feelings,
and behaviors, as well as helpful states of mind and gratitude
4. Lifestyle module - helping patients practice skills for saving up energy and using
self-care strategies
5. 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.
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
Massachusetts General Hospital
Boston, Massachusetts, United States
Investigator: Areej El-Jawahri, MD
Contact: 617-724-4000
ael-jawahri@partners.org
Investigator: Areej El-Jawahri, MD
Areej El-Jawahri, MD
617-724-4000
ael-jawahri@mgb.org
Hermioni Amonoo, MD, MPP
hlokko@mgh.harvard.edu
Areej El-Jawahri, MD, Principal Investigator
Massachusetts General Hospital