Trial of Oral Lenalidomide Stewardship Program for Veterans

NCT04835220 | Unknown

• 1 other identifier: 17-42
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To address the challenge of oral chemotherapy stewardship in the Veteran population, this study outlines the implementation and evaluation of a pilot program for the delivery and management of lenalidomide to increase the adherence rates. Our goal is to utilize a team-based multi-disciplinary approach using existing technological resources such as the tele-oncology program at the Salisbury VA and other VA medical centers to provide cancer care that is safe, effective, compassionate, and cost-effective. Subject will be prescribed a Lenalidomide based therapy per standard of care. Eligibility is based only on a prescription for Lenalidomide and is independent of any other concurrent treatments for myeloma. The objectives are as followed: 1. To describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide. 2. To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide.

Conditions

Medication Compliance

Outcome Measures

Primary Outcomes (1)

• Adherence of medication compliance

  To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide. Adherence of veterans to their prescribed lenalidomide treatment will be measured based on MEMs bottle cap data. A descriptive analysis using data from the MGL Scale (asked during the telehealth call) will be conducted to describe adherence in the stewardship assistance program cohort. Of note, patients in the intervention arm who stop attending telehealth calls prior to the completion of the patient stewardship program will still be considered as part of the intervention arm (i.e., an "intent-to-treat analysis"). However, data on the participation in the patient stewardship program (e.g., number of telehealth visits attended), will be collected and may be used in sensitivity analyses if appropriate.

  12 Months

Secondary Outcomes (1)

• Clinical Characteristics

  12 months

Study Arms (2)

Control Group

NO INTERVENTION

Electronic pill bottle cap (MEMs bottle cap) with no Telehealth calls

Telehealth intervention group

OTHER

Electronic pill bottle cap (MEMs bottle cap) with regular telehealth visits to the veterans at the VAMCs on the stewardship program. These visits will involve contacting the veterans by telephone, administering a questionnaire to review their medication-taking behavior for oral chemotherapy, and potentially contacting the treating oncologist in the event that the veterans are at risk of non-adherence (based on their responses).

Other: Telehealth Calls

Interventions

Telehealth Calls OTHER

The telehealth nurse will record data in a case report form within the VA REDCap electronic data capture system that is stored within the VA firewall.

Telehealth intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with myeloma or Initiating lenalidomide maintenance therapy after transplant or transplant ineligible patients that are started on lenalidomide until progression or intolerance.
• Myeloma diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\] codes:vC90.00 or associated diagnosis )
• Prescription for lenalidomide
• Planned or Currently treated with lenalidomide as part of a treatment regimen for newly diagnosed myeloma
• Renal function assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl):
• Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. (See Appendix C). Dosing for patients with creatinine clearance between 30ml/min-60ml/min will be based on lenalidomide package insert.
• Total bilirubin 1.5 x ULN
• AST (SGOT) and ALT (SGPT) 3 x ULN.
• All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• Able to take prophylactic anticoagulation such as aspirin, warfarin, low molecular weight heparin or direct oral anticoagulant.
• Personal Computer with internet Capability.

You may not qualify if:

• \< 18 years of age as of the index date
• Newly diagnosed with myeloma and not started on lenalidomide
• Known hypersensitivity to thalidomide or lenalidomide (if applicable).
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
• Females who are pregnant.

Sponsors & Collaborators

• W.G. Bill Hefner Medical Center: lead

Study Sites (1)

W.G. Bill Hefner VAMC

Salisbury, North Carolina, 28144, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Telehealth intervention group and a control group.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: March 26, 2021
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)