Lenalidomide Adherence in Older Adults

Terminated

• Conditions: Multiple Myeloma
• Interventions: Other: Medication Event Monitoring System

• Registration Number: NCT03779555
• Lead Sponsor: Washington University School of Medicine

Brief Summary

To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-12-13
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age ≥65
• Receiving lenalidomide for treatment of multiple myeloma.
• Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
• Able to read and understand English.
• Able to understand and willing to sign an IRB-approved written informed consent document.

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Exclusion Criteria

• Estimated life expectancy <6 months.
• Anticipated duration of lenalidomide therapy <3 months.
• Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients taking lenalidomide for multiple myeloma	Medication Event Monitoring System	-Patients will be seen at baseline, 1 month (+/- 1 week), 2 months (3-5 weeks following 1-month assessment), and 3 months (3-5 weeks after 2-month follow-up)

Primary Outcome Measures

Name	Time	Method
Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open	Through completion of study (estimated to be 3 months)	-Participants will be given a pill diary in which they will record if they opened the pill bottle without taking a medication (e.g. to ascertain remaining supply) to adjust the adherence rate accordingly

Secondary Outcome Measures

Name	Time	Method
Adherence rate as measured by a modified Brief Adherence Rating Scale	Through completion of study (estimated to be 3 months)	* Participants will fill out a brief survey about taking lenalidomide and an estimate of their adherence using a visual analog scale; * Scored 0-100%, 0% = lenalidomide not taken on any days and 100% = lenalidomide taken every day

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States