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

NCT03777306 | Completed

• 2 other identifiers: IRB-300000121PackHealth/Amgen
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Educational intervention

Outcome Measures

Primary Outcomes (3)

• Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety

  We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety

  Baseline

• Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety

  We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety

  12 weeks post intervention

• Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety

  We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety

  24 weeks post intervention

Secondary Outcomes (9)

• Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression

  Baseline

• Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression

  12 weeks post intervention

• Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression

  24 weeks post intervention

• Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy

  Baseline

• 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

Other Outcomes (3)

• Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires

  Baseline

• 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

  12 weeks post intervention

• 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

  24 weeks post intervention

Study Arms (2)

ARM A EARLY INTERVENTION GROUP

EXPERIMENTAL

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

Other: ARM A EARLY INTERVENTION GROUP

ARM B DELAYED INTERVENTION GROUP

EXPERIMENTAL

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

Other: ARM B DELAYED INTERVENTION GROUP

Interventions

ARM A EARLY INTERVENTION GROUP OTHER

Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive * 1 video/picture/worksheet per week covering the topic to be covered. * 1 phone/week by the Health Advisor, to discuss the topic for the week s/as their disease, stress and anxiety management, life organization, adherence skills, healthy eating and sleeping). Participant and the health advisor will also set up a "Tiny Step"" to serve as a goal for the week . * 3 emails/texts through the week, to remind about the topic covered, or to encourage them on their Tiny Step goal. After 12 weeks on the program participants will re-take the surveys to assess the level of stress.

ARM A EARLY INTERVENTION GROUP

ARM B DELAYED INTERVENTION GROUP OTHER

The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention

ARM B DELAYED INTERVENTION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• PackHealth/Amgen: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Smith Giri, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: December 17, 2018
• Study Start: November 27, 2017
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: April 20, 2026

Record last verified: 2025-12

Locations

US (1)