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ARM B DELAYED INTERVENTION GROUP for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, ALMultiple MyelomaARM B DELAYED INTERVENTION GROUP - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Dietary Intervention
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Ipilimumab

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Baseline

12 weeks post intervention
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
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 patient improvement in adherence to myeloma specific medication and treatment schedules 12 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
24 weeks post intervention
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
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
Assess patient improvement in adherence to myeloma specific medication and treatment schedules 24 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
Baseline
Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
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

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ABSK061
1
Dietary Intervention
2
Ipilimumab

Trial Design

2 Treatment Groups

ARM A EARLY INTERVENTION GROUP
1 of 2
ARM B DELAYED INTERVENTION GROUP
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: ARM B DELAYED INTERVENTION GROUP · No Placebo Group · N/A

ARM A EARLY INTERVENTION GROUP
Other
Experimental Group · 1 Intervention: ARM A EARLY INTERVENTION GROUP · Intervention Types: Other
ARM B DELAYED INTERVENTION GROUP
Other
Experimental Group · 1 Intervention: ARM B DELAYED INTERVENTION GROUP · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,446 Previous Clinical Trials
2,235,506 Total Patients Enrolled
10 Trials studying Multiple Myeloma
6,874 Patients Enrolled for Multiple Myeloma
Smith Giri, MDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the study if you have previously participated in a multiple myeloma study that did not involve any psychological or educational intervention.
You must have access to either SMS texting or email to receive messages of encouragement.
You have any other medical condition that might put you at risk or affect the study's evaluation or completion according to the investigator or Amgen physician.
References

Frequently Asked Questions

Is there currently an opportunity to join this medical research?

"The clinical trial's listing on clinicialtrials.gov confirms that it is not seeking participants at present, with the initial post date being November 27th 2017 and the most recent edit taking place on November 29th 2022. Despite this study's closure to enrollment, there are currently 807 studies actively recruiting subjects across multiple sites." - Anonymous Online Contributor

Unverified Answer

What objectives is this research endeavor trying to accomplish?

"As the primary outcome of this trial, over a Baseline time frame, investigators will measure MM patients’ levels of anxiety 24 weeks after completing an educational program (MPI) using the PROMIS assessment tool for Anxiety. Other indicators to be measured include baseline depression levels prior to implementation with the same instrument as well as 12 and 24-week postintervention evaluation of patient self-efficacy for symptom management and depression respectively." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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