The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional supportive care trial for Multiple Myeloma focused on measuring Educational intervention
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
ARM A EARLY INTERVENTION GROUP
ARM B DELAYED INTERVENTION GROUP
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