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NCT Number: NCT06073353

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THRIVE-M

Behavioral

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.

Primary outcomes

  1. Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Quality of life longitudinally based on the FACT-MM scale

    Time frame: Up to 15 weeks

    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.

  2. Anxiety Symptoms based on the Hospital Anxiety and Depression Scale

    Time frame: Up to 15 weeks

    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.

  3. Depression Symptoms based on the Hospital Anxiety and Depression Scale

    Time frame: Up to 15 weeks

    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.

  4. Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist

    Time frame: Up to 15 weeks

    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.

  5. Fatigue based on the FACT-Fatigue Scale

    Time frame: Up to 15 weeks

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: THRIVE-M

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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