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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Characteristics | Describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide. | 12 months |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W.G. Bill Hefner VAMC | Salisbury | North Carolina | 28144 | United States |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Telehealth intervention group and a control group.
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| D001519 | Behavior |