An Analysis of Medication Adherence Using Televideo and Telephonic Monitoring and Utilization of an Education Protocol
NCT ID: NCT06696521
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2021-02-09
2025-02-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Telephonic and telemedicine evaluation
Patients will be randomized to telephonic or telemedicine evaluation during participation in the study
Intervention A- Telephone
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.
Intervention B- Televideo
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.
Interventions
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Intervention A- Telephone
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.
Intervention B- Televideo
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Elizabeth Prechtel Dunphy, DNP, RN, ANP-BC, AOCN
DNP, CRNP
Locations
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Abramson Cancer Center at PPMC
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UPCC24220
Identifier Type: -
Identifier Source: org_study_id
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