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

NCT06073353 | Active Not Recruiting

• 1 other identifier: 23-332
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Fatigue based on the FACT-Fatigue Scale

  Up to 15 weeks

Study Arms (2)

THRIVE-M

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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).

Interventions

THRIVE-M BEHAVIORAL

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.

THRIVE-M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients with acute or unstable psychiatric or cognitive conditions that the treating clinicians believe prohibit informed consent or compliance with study procedures

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: October 10, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Mass General Brigham innovations team at http://www.partners.org/innovation

Locations

US (1)