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

NCT ID: NCT03777306

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2024-11-22

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ARM A EARLY INTERVENTION GROUP

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

Group Type: EXPERIMENTAL

ARM A EARLY INTERVENTION GROUP

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

ARM B DELAYED INTERVENTION GROUP

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Smith Giri

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Smith Giri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300000121

Identifier Type: -

Identifier Source: org_study_id