The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: ARM A EARLY INTERVENTION GROUP; Other: ARM B DELAYED INTERVENTION GROUP

• Registration Number: NCT03777306
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the anxiety and depression they suffer due to a poor understanding of their disease. Improving patient understanding of their illness and addressing issues that induce distress impacts QoL. This prospective, interventional study is designed to see if a structured psycho-educational program called "the myeloma pack intervention" (MPI), implemented in parallel with standard cancer treatment, can improve QoL for patients with MM.

Detailed Description

The purpose of this research study is to see if the MPI educational program, implemented in parallel with standard of care treatment, can improve overall quality of life (QoL) for MM patients. This program will be delivered to the study participants by multiple modes of communication including written material in a boxed pack, online tutorials, telephone and text message follow up. If they do not have online access at home, the study coordinators will arrange access for the participants at the Clinic. A health advisor will work with the physicians to coordinate their participation in the program while they are on active treatment for myeloma. The Pack Health Advisors will only give them guidance about the study and they will not provide any kind of clinical advice to the participants.

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Status Verified: 2024-11
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Of age ≥18 years or older.
• Having a diagnosis of MM; newly diagnosed or relapsed/refractory disease
• Undergoing systemic treatment through the UAB MM Clinic Pathway
• Able to provide informed consent to be included in the intervention
• MM patients in a prior/concurrent (non-pyscho/educational intervention), MM study will be eligible to participate
• Have either SMS texting or email access to receive encouragement messages

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Exclusion Criteria

Patients will be ineligible for the program if they are:

• Being treated by end-of-life or comfort care measures only
• MM patients not treated through the UAB MM Clinic Pathway.
• MM patients not requiring systemic therapy.
• Patients with a diagnosis of MGUS or SMM.
• Have a history of other malignancy within the past [3 or 5] years with the exception of:
• Malignancies treated with curative intent and with no known active disease present for ≥ 3 (or 5) years before enrollment and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Adequately treated breast ductal carcinoma in situ without evidence of disease
• Prostatic intraepithelial neoplasia without evidence of prostate cancer
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
• Are enrolled in a prior/concurrent MM psycho-educational study

Other Exclusions:

• Patients who do not have either SMS texting or email access to receive encouragement messaging will be excluded
• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARM A EARLY INTERVENTION GROUP	ARM A EARLY INTERVENTION GROUP	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
ARM B DELAYED INTERVENTION GROUP	ARM B DELAYED INTERVENTION GROUP	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

Primary Outcome Measures

Name	Time	Method
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	24 weeks post intervention	We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	Baseline	We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	12 weeks post intervention	We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety

Secondary Outcome Measures

Name	Time	Method
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy	Baseline	We will assess baseline patient self-efficacy for symptom management in MM patients before the implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression	Baseline	We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy	24 weeks post intervention	We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
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	12 weeks post intervention	We will assess outcomes 12 weeks after implementation of educational program (MPI) 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	12 weeks post intervention	We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
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	24 weeks post intervention	We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression	12 weeks post intervention	We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression	24 weeks post intervention	We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index	Baseline	We will baseline assess patient adherence to myeloma specific medication and treatment schedules in MM patients before the implementation of educational program (MPI) using the CASE Medication Adherence Index

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States