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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: ARM A EARLY INTERVENTION GROUP
* Other: ARM B DELAYED INTERVENTION GROUP


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A EARLY INTERVENTION GROUP<br>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<br>* 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.<br>|
| Experimental: ARM B DELAYED INTERVENTION GROUP<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Educational intervention