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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03777306
• Other study ID #: IRB-300000121
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• ARM 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.
• ARM 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires	We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires	Baseline
Other	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	We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires	12 weeks post intervention
Other	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	We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires	24 weeks post intervention
Primary	Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety	Baseline
Primary	Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety	12 weeks post intervention
Primary	Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety	We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety	24 weeks post intervention
Secondary	Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression	We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression	Baseline
Secondary	Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression	We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression	12 weeks post intervention
Secondary	Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression	We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression	24 weeks post intervention
Secondary	Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy	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	Baseline
Secondary	Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy	We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy	12 weeks post intervention
Secondary	Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy	We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy	24 weeks post intervention
Secondary	Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index	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	Baseline
Secondary	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	We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index	12 weeks post intervention
Secondary	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	We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index	24 weeks post intervention