Clinical trial NCT06073353: Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma
Official title: Randomized Controlled Trial of a Psychosocial Mobile Application (THRIVE-M) for Patients Living With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of life longitudinally based on the FACT-MM scale
timeFrame: Up to 15 weeks
measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale
timeFrame: Up to 15 weeks
measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale
timeFrame: Up to 15 weeks
measure: Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist
timeFrame: Up to 15 weeks
measure: Fatigue based on the FACT-Fatigue Scale
timeFrame: Up to 15 weeks
Other outcomes:
measure: Coping based on the Measure of Current Status Part A (MOCS-A) scale
timeFrame: Up to 15 weeks
measure: Self-efficacy based on the Cancer Self-Efficacy Scale (CASE)
timeFrame: Up to 15 weeks
measure: Spiritual Well-being based on the FACT-spiritual scale
timeFrame: Up to 15 weeks
measure: Optimism based on the Life Orientation Test-Revised (LOT-R) scale
timeFrame: Up to 15 weeks
measure: Life Satisfaction based on the Satisfaction with Life Scale (SWLS)
timeFrame: Up to 15 weeks
measure: Positive Affect based on the Positive Affect Schedule (PANAS)
timeFrame: Up to 15 weeks
measure: Gratitude based on the Gratitude Questionniare-6
timeFrame: Up to 15 weeks
measure: Loneliness based on the Cancer Loneliness Scale (CLS)
timeFrame: Up to 15 weeks
measure: Usability of THRIVE-M app based on the System Usability Scale
timeFrame: Up to 8 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: