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| ID | Type | Description | Link |
|---|---|---|---|
| PackHealth/Amgen | Other Identifier | PackHealth/Amgen |
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| Name | Class |
|---|---|
| PackHealth/Amgen | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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
After 12 weeks on the program participants will re-take the surveys to assess the level of stress. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires | We will baseline QoL in MM patients before implementation of educational program (MPI) 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients will be ineligible for the program if they are:
Other Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Smith Giri, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
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| 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 |
|
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 |
We will assess outcomes 12 weeks after implementation of educational program (MPI) 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 | We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires | 24 weeks post intervention |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |