Clinical trial NCT03777306: The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
Official title: The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Educational intervention
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
timeFrame: Baseline
measure: Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
timeFrame: 12 weeks post intervention
measure: Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
timeFrame: 24 weeks post intervention
Secondary outcomes:
measure: Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
timeFrame: Baseline
measure: Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
timeFrame: 12 weeks post intervention
measure: Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
timeFrame: 24 weeks post intervention
measure: Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
timeFrame: Baseline
measure: Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
timeFrame: 12 weeks post intervention
measure: Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
timeFrame: 24 weeks post intervention
measure: Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
timeFrame: Baseline
measure: 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
timeFrame: 12 weeks post intervention
measure: 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
timeFrame: 24 weeks post intervention
Other outcomes:
measure: Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
timeFrame: Baseline
measure: 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
timeFrame: 12 weeks post intervention
measure: 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
timeFrame: 24 weeks post intervention
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Smith Giri, MD
role: PRINCIPAL_INVESTIGATOR
References: