Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

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, 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

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

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

Smith Giri, MD

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.

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.

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

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

We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires

We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires

We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires

We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) 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

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

We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression

We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression

We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression

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

We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy

We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy

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

We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index

We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma	NCT03777306	Multiple Myelom...	ARM A EARLY INT... ARM B DELAYED I...	18 Years -	University of Alabama at Birmingham
The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma	NCT03777306	Multiple Myelom...	ARM A EARLY INT... ARM B DELAYED I...	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for arm a early intervention group