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Educational Program for Multiple Myeloma

N/A
Waitlist Available
Led By Smith Giri, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post intervention
Awards & highlights

Study Summary

This trial will test whether a structured educational program can improve quality of life for patients with multiple myeloma.

Who is the study for?
This trial is for adults over 18 with Multiple Myeloma, either newly diagnosed or relapsed/refractory, who are receiving systemic treatment. Participants must have access to SMS texting or email and be able to consent. Those in other psycho-educational studies or with significant health risks unrelated to MM are excluded.Check my eligibility
What is being tested?
The study tests 'the myeloma pack intervention' (MPI), a structured psycho-educational program alongside standard cancer care, aiming to improve quality of life by enhancing disease understanding and reducing anxiety and depression among MM patients.See study design
What are the potential side effects?
Since the intervention involves educational materials and encouragement messages rather than medical treatments, there are no direct side effects associated with typical drug interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Secondary outcome measures
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
Pharmaceutical Preparations
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
+6 more
Other outcome measures
Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Assess effect on Qualityof Life (QoL) 12 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Assess effect on Qualityof Life (QoL) 24 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARM B DELAYED INTERVENTION GROUPExperimental Treatment1 Intervention
Arm B, is a wait-list control group that will serve as the control. The wait-list control group will be observed for an initial 12 week period while receiving usual care and then have the educational intervention implemented from week 12-24 in parallel with standard of care
Group II: ARM A EARLY INTERVENTION GROUPExperimental Treatment1 Intervention
In Arm A, the intervention group, the participants will start on the program immediately. The participants will receive MPI educational program, implemented in parallel with standard of care treatment. The MPI is implemented at the time of enrollment x 12 weeks

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,597 Previous Clinical Trials
2,284,028 Total Patients Enrolled
10 Trials studying Multiple Myeloma
6,935 Patients Enrolled for Multiple Myeloma
Smith Giri, MDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham

Media Library

The Myeloma Pack Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03777306 — N/A
Multiple Myeloma Research Study Groups: ARM B DELAYED INTERVENTION GROUP, ARM A EARLY INTERVENTION GROUP
Multiple Myeloma Clinical Trial 2023: The Myeloma Pack Intervention Highlights & Side Effects. Trial Name: NCT03777306 — N/A
The Myeloma Pack Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03777306 — N/A
~7 spots leftby Dec 2024