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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARM A EARLY INTERVENTION GROUP
ARM B DELAYED INTERVENTION GROUP
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Educational intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

ARM A EARLY INTERVENTION GROUP

ARM B DELAYED INTERVENTION GROUP

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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

Full Information

First Posted
September 27, 2018
Last Updated
November 29, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03777306
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Educational intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A EARLY INTERVENTION GROUP
Arm Type
Experimental
Arm Description
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 Title
ARM B DELAYED INTERVENTION GROUP
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ARM A EARLY INTERVENTION GROUP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ARM B DELAYED INTERVENTION GROUP
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Description
We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time Frame
Baseline
Title
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Description
We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time Frame
12 weeks post intervention
Title
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Description
We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time Frame
24 weeks post intervention
Secondary Outcome Measure Information:
Title
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
Description
We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
Time Frame
Baseline
Title
Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
Description
We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
Time Frame
12 weeks post intervention
Title
Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
Description
We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
Time Frame
24 weeks post intervention
Title
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
Description
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
Time Frame
Baseline
Title
Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
Description
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Time Frame
12 weeks post intervention
Title
Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
Description
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Time Frame
24 weeks post intervention
Title
Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
Description
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
Time Frame
Baseline
Title
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
Description
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Time Frame
12 weeks post intervention
Title
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
Description
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Time Frame
24 weeks post intervention
Other Pre-specified Outcome Measures:
Title
Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Description
We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame
Baseline
Title
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
Description
We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame
12 weeks post intervention
Title
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
Description
We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame
24 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smith Giri, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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