Multiple Myeloma
Conditions
Keywords
Educational intervention
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.
Interventions
OTHERARM A EARLY INTERVENTION GROUP
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.
OTHERARM B DELAYED 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
Sponsors
University of Alabama at Birmingham
PackHealth/Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 |
| 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 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSmith Giri, MD
University of Alabama at Birmingham
Outcome results
None listed