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

NCT06696521 | Completed

• 1 other identifier: UPCC24220
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication; Cancer

Outcome Measures

Primary Outcomes (3)

• Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)?

  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.

  Through study completion, approximately 4 months

• Will modality of outreach impact adherence based on medication pill counts?

  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.

  Through study completion, approximately 4 months

• Will modality of outreach impact adherence based on Oral Chemotherapy Adherence Scale (OCAS)?

  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

  Through study completion, approximately 4 months

Study Arms (1)

Telephonic and telemedicine evaluation

OTHER

Patients will be randomized to telephonic or telemedicine evaluation during participation in the study

Behavioral: Intervention A- Telephone; Behavioral: Intervention B- Televideo

Interventions

Intervention A- Telephone BEHAVIORAL

For intervention A: Once a patient is randomized to telephone (Intervention A), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first 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 through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months.

Telephonic and telemedicine evaluation

Intervention B- Televideo BEHAVIORAL

For intervention B: Once a patient is randomized to televideo (Intervention B), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first 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 through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months.

Telephonic and telemedicine evaluation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not desire to participate in the study
• Cannot consent for himself/herself
• Does not have access to the UPENN televideo platform
• Does not live in Pennsylvania
• Chemoradiation patients

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center at PPMC

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (12)

• Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.

  PMID: 22486599 BACKGROUND

• Voils CI, Venne VL, Weidenbacher H, Sperber N, Datta S. Comparison of Telephone and Televideo Modes for Delivery of Genetic Counseling: a Randomized Trial. J Genet Couns. 2018 Apr;27(2):339-348. doi: 10.1007/s10897-017-0189-1. Epub 2017 Dec 15.

  PMID: 29243007 BACKGROUND

• Tipton JM. Overview of the challenges related to oral agents for cancer and their impact on adherence. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):37-40. doi: 10.1188/15.S1.CJON.37-40.

  PMID: 26030391 BACKGROUND

• Spoelstra SL, Rittenberg CN. Assessment and measurement of medication adherence: oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):47-52. doi: 10.1188/15.S1.CJON.47-52.

  PMID: 26030393 BACKGROUND

• Spoelstra SL, Given CW. Assessment and measurement of adherence to oral antineoplastic agents. Semin Oncol Nurs. 2011 May;27(2):116-32. doi: 10.1016/j.soncn.2011.02.004.

  PMID: 21514481 BACKGROUND

• Sirintrapun SJ, Lopez AM. Telemedicine in Cancer Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:540-545. doi: 10.1200/EDBK_200141.

  PMID: 30231354 BACKGROUND

• Burhenn PS, Smudde J. Using tools and technology to promote education and adherence to oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):53-9. doi: 10.1188/15.S1.CJON.53-59.

  PMID: 26030395 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

  PMID: 31912902 BACKGROUND

• McCabe CC, Barbee MS, Watson ML, Billmeyer A, Lee CE, Rupji M, Chen Z, Haumschild R, El-Rayes B. Comparison of rates of adherence to oral chemotherapy medications filled through an internal health-system specialty pharmacy vs external specialty pharmacies. Am J Health Syst Pharm. 2020 Jul 7;77(14):1118-1127. doi: 10.1093/ajhp/zxaa135.

  PMID: 32537656 BACKGROUND

• Jacobs JM, Ream ME, Pensak N, Nisotel LE, Fishbein JN, MacDonald JJ, Buzaglo J, Lennes IT, Safren SA, Pirl WF, Temel JS, Greer JA. Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life. J Natl Compr Canc Netw. 2019 Mar 1;17(3):221-228. doi: 10.6004/jnccn.2018.7098.

  PMID: 30865917 BACKGROUND

• Bertsch NS, Bindler RJ, Wilson PL, Kim AP, Ward B. Medication Therapy Management for Patients Receiving Oral Chemotherapy Agents at a Community Oncology Center: A Pilot Study. Hosp Pharm. 2016 Oct;51(9):721-729. doi: 10.1310/hpj5109-721.

  PMID: 27803501 BACKGROUND

• Bagcivan G, Akbayrak N. Development and Psychometric Testing of the Turkish-Version Oral Chemotherapy Adherence Scale. J Nurs Res. 2015 Dec;23(4):243-51. doi: 10.1097/JNR.0000000000000101.

  PMID: 26562455 BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Neoplasms

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DNP, CRNP

Model Details: Patients randomized to telephonic or televideo participation once enrolled in the study.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: November 20, 2024
• Study Start: February 9, 2021
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)