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Digital Health Coaching for Multiple Myeloma

N/A

Recruiting

Led By Rahul Banerjee, MD

Research Sponsored by Pack Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.

Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and/or one immunomodulatory drug (IMiD).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment up to 3 months

Awards & highlights

Study Summary

This trial will investigate how digital health coaching can help adults with relapsed/refractory multiple myeloma (R/R MM) with their treatment, symptoms, quality of life, financial burden, and confidence to manage their health.

Who is the study for?

Adults over 18 with relapsed or refractory multiple myeloma, who have undergone at least one prior treatment including a proteasome inhibitor or immunomodulatory drug. Not for those with less than 6 months to live, without smartphone access, insufficient English proficiency, or on conflicting R/R MM studies.Check my eligibility

What is being tested?

The trial is testing a digital health coaching program that includes weekly phone calls and educational materials via text/email. Participants will also use a Fitbit to track activity levels. The focus is on the impact of this program on quality of life and healthcare management confidence.See study design

What are the potential side effects?

Since this study involves non-drug interventions (digital coaching and Fitbit), traditional medication side effects are not expected. However, participants may experience stress or discomfort from frequent communication or wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma, and I may also have AL amyloidosis.

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I am starting my second or later treatment for multiple myeloma and have previously been treated with a PI or IMiD.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of the Digital Health Coaching Intervention

Secondary outcome measures

Change in Cancer Behavior Inventory-Brief Form (CBI-B)

Other outcome measures

Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index

Change in Comprehensive Score for Financial Toxicity (COST) Instrument

Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm Cohort Receiving Digital Health CoachingExperimental Treatment2 Interventions

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fitbit

2021

N/A

~3560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pack HealthLead Sponsor

5 Previous Clinical Trials

1,068 Total Patients Enrolled

2 Trials studying Multiple Myeloma

100 Patients Enrolled for Multiple Myeloma

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,660 Total Patients Enrolled

8 Trials studying Multiple Myeloma

369 Patients Enrolled for Multiple Myeloma

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,735 Total Patients Enrolled

47 Trials studying Multiple Myeloma

6,333 Patients Enrolled for Multiple Myeloma

Media Library

Single Arm Cohort Receiving Digital Health Coaching Clinical Trial Eligibility Overview. Trial Name: NCT05956457 — N/A

Multiple Myeloma Research Study Groups: Single Arm Cohort Receiving Digital Health Coaching

Multiple Myeloma Clinical Trial 2023: Single Arm Cohort Receiving Digital Health Coaching Highlights & Side Effects. Trial Name: NCT05956457 — N/A

Single Arm Cohort Receiving Digital Health Coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT05956457 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been included in this clinical trial thus far?

"Affirmative. The clinicaltrials.gov webpage states that this trial is currently soliciting participants, which was first made public on July 20th of 2023 and last revised 13 days later. A total of 100 volunteers are sought from 1 distinct medical facility."

Answered by AI

Is this experiment in need of participants at the present time?

"According to the details provided on clinicaltrials.gov, patient recruitment for this experiment is still open as of July 13th 2023. This research was initially advertised on July 20th 2023."

Answered by AI

Recent research and studies

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