Multiple MyelomaTHRIVE-MNCT06073353

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

A study testing THRIVE-M in people with Multiple Myeloma, run by Massachusetts General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: THRIVE-M
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to 1 Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

Read the 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.

Conditions: Multiple Myeloma
Being tested: THRIVE-M
Keywords: Multiple Myeloma
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THRIVE-MBehavioural
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.

Study groups in NCT06073353
Study group	Role	What they receive
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. Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (5)

Quality of life longitudinally based on the FACT-MM scale
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.
Measured: Up to 15 weeks
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale
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.
Measured: Up to 15 weeks
Depression Symptoms based on the Hospital Anxiety and Depression Scale
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.
Measured: Up to 15 weeks
Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist
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.
Measured: Up to 15 weeks
Fatigue based on the FACT-Fatigue Scale
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.
Measured: Up to 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20231 Nov 2026

First posted10 Oct 2023
Study start1 Dec 2023
Primary completion1 Apr 2025
Study completion1 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06073353
Sponsor's protocol ID: 23-332
Acronym: THRIVE-M
Status last verified: May 2026
First submitted: 2 Sep 2023
Last updated: 14 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of a Psychosocial Mobile Application (THRIVE-M) for Patients Living With Multiple Myeloma
ClinicalTrials.gov ID: NCT06073353
Acronym / sponsor ID: THRIVE-M / 23-332
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 1 Apr 2025 (actual)
Study completion: 1 Nov 2026 (estimated)
First posted: 10 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Divine Mercy University is funding this research study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
THRIVE-M	Experimental	Behavioral: THRIVE-MParticipants 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.
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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult patients (aged 18 years or older) with one of the following diagnoses:
Ability to comprehend, read, and respond to questions in English

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THRIVE-MTHRIVE-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.	Behavioural	THRIVE-M

Primary outcome

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.

5 secondary outcomes

Quality of life longitudinally based on the FACT-MM scale
Time frame: Up to 15 weeks
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale
Time frame: Up to 15 weeks
Depression Symptoms based on the Hospital Anxiety and Depression Scale
Time frame: Up to 15 weeks
Post-traumatic Stress Disorder (PTSD) Symptoms based on the PTSD Checkist
Time frame: Up to 15 weeks
Fatigue based on the FACT-Fatigue Scale
Time frame: Up to 15 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Areej El-Jawahri, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing THRIVE-M in people with Multiple Myeloma, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06073353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.