An Analysis of Medication Adherence Using Televideo and Telephonic Monitoring and Utilization of an Education Protocol

Not Applicable

Completed

• Conditions: Adherence, Medication; Cancer

• Registration Number: NCT06696521
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Researchers aim to evaluate whether the modality of education and monitoring impact adherence.

Detailed Description

The study will consist of eight total interactions. We will allow for a 72 hour window for each encounter to allow for patient flexibility and scheduling. The first encounter will include medication education using the standardized tool. The remaining seven interactions will include toxicity and adherence assessment through patient interviews, the OCAS, pill counts, and pharmacy fill data. All interactions will be completed via telephonic outreach or televideo platform by either CRNP, PA-C or PharmD. The patient will be approached when an OCA is prescribed to be given a copy of the OncoLink® patient education material and consent form for review. Patients will be randomized 1:1 to either televideo or telephonic interactions using a block size of 4. All study staff will be blinded to block size. Once a patient is randomized, s/he will be scheduled for the series of follow up encounters via the assigned modality. The first telemedicine interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second encounter will occur approximately 2 weeks after the patient starts the medication to assess for adherence and toxicity. The third through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS) (Bagcivan and Akbayrak 2015) will be completed per standard of care in addition to patient interview to assess adherence and toxicity. Fill history will be obtained prior to each interaction to verify medication possession ratio and proportion of days covered.

Each patient in the study will participate for a duration of up to 4 months. All of the research will take place at the Abramson Cancer Center at Penn Presbyterian Medical Center.

Study Timeline

• Study Start: 2021-02-09
• Study First Submitted: 2024-09-18
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-16
• Study First Posted: 2024-11-20
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Has a diagnosis of cancer
2. Receives cancer care at Abramson Cancer Center at Penn Presbyterian Medical Center
3. Physically and cognitively able to provide informed consent
4. Is 18 years or older
5. Is starting an oral cancer agent
6. Has access to the UPENN televideo platform
7. Lives in Pennsylvania

Exclusion Criteria

1. Does not desire to participate in the study
2. Cannot consent for himself/herself
3. Does not have access to the UPENN televideo platform
4. Does not live in Pennsylvania
5. Chemoradiation patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)?	Through study completion, approximately 4 months	The MPR and PDC will be calculated along with pill count and OCAS with each interaction through study completion and then evaluated for the individual patient and as an aggregate for all participants.
Will modality of outreach impact adherence based on medication pill counts?	Through study completion, approximately 4 months	This will be measured with patient providing pill count at time of each interaction. MPR and PDC will also be calculated with each interaction to determine patient's compliance evaluating medication fill/refill information.
Will modality of outreach impact adherence based on Oral Chemotherapy Adherence Scale (OCAS)?	Through study completion, approximately 4 months	The OCAS will be completed with each interaction and scored using the grading criteria of the scale authors. The OCAS scale contains 19 questions that are graded from 1-5 based on answer for a total score. A score of 84 and higher is classified as good adherence and a score of 83 and lower is classified as bad adherence. The highest score is 95 and the lowest score is 19. This calculation will be made with each interaction through the study completion. The scores will be analyzed for each patient and as an aggregate and compared between the groups

Trial Locations

Locations (1)

Abramson Cancer Center at PPMC; 🇺🇸 Philadelphia, Pennsylvania, United States