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

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

NCT ID: NCT06073353

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Conditions: Keywords:
Multiple Myeloma

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: 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.

Intervention:

Intervention type: Behavioral
Intervention name: THRIVE-M
Description: 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.
Arm group label: THRIVE-M

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Status: Recruiting

Contact:
Last name: Areej El-Jawahri, MD

Phone: 617-724-4000
Email: ael-jawahri@partners.org

Investigator:
Last name: Areej El-Jawahri, MD
Email: Principal Investigator

Start date: December 1, 2023

Completion date: March 31, 2025

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06073353