Multiple Myeloma Clinical Trial

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

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.

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Full 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.

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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.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT03777306

Recruitment Status:

Active, not recruiting

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT03777306

Recruitment Status:

Active, not recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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