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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:November 27, 2017
End Date:September 17, 2020
Contact:Study Coordinator
Email:bmuse@uabmc.edu
Phone:205-934-3792

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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.

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.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Racquel Innis-Shelton, MD
Phone: 205-934-3792
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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mi
from
Birmingham, AL
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