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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreOther study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,616 Total Patients Enrolled
11 Trials studying Multiple Myeloma
7,385 Patients Enrolled for Multiple Myeloma
Smith Giri, MDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who have taken part in a different study for multiple myeloma that did not involve psychological or educational treatment can join this study.I have multiple myeloma but don't need systemic therapy.I have been diagnosed with MGUS or SMM.I can receive texts or emails for encouragement.I am 18 years old or older.I am only receiving care to make me comfortable in my final days.I have been diagnosed with multiple myeloma, either newly or it has returned.I don't have any health conditions that could risk my safety in the study.You are currently participating in a mental health education study for multiple myeloma.Currently receiving treatment through the UAB MM Clinic Pathway.Multiple myeloma patients who are not receiving treatment through the UAB Multiple Myeloma Clinic Pathway.I haven't had any other cancer in the last 3 to 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: ARM B DELAYED INTERVENTION GROUP
- Group 2: ARM A EARLY INTERVENTION GROUP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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