- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04990934
Transitioning Care: Perspectives of Older Women With Early Breast Cancer on Current Telemedicine Modalities
Explosive growth in the use of telemedicine (video or telephone visits) has followed the onset of the coronavirus disease 2019 (COVID-19) pandemic in order to meet healthcare needs while avoiding unnecessary exposure risks in ambulatory care spaces. Accordingly, in March 2020, the Centers for Medicare & Medicaid Services expanded reimbursement for telemedicine visits to equal that of in-person services. The policy and infrastructure that enabled this emergency transition is laying the groundwork for enduring expansion of elective telemedicine, a technology that could significantly decrease the burden of medical care in older patients with cancer. To benefit from telehealth, patients must have a certain level of knowledge and capacity to engage with technology, which can be a challenge for some older adults because of inexperience, access, and disability. As cancer is mainly a disease of older adults, with a median age of 65 at diagnosis for most cancer types, this is a significant limitation on the utility of telemedicine in oncology.
The goal of our study is to better understand older breast cancer patients' experiences with telephone and video telemedicine with regard to visit convenience, completeness, and interpersonal satisfaction through semi-structured interviews with patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods:
30 participants will be consented in this study. 20 will have participated in video telemedicine appointments with their treating breast cancer oncologists, and 10 will have used telephone. Semi-structured interviews lasting no more than 30 minutes will be conducted to ascertain the participant's (1) reason for choosing a certain telemedicine modality, (2) perception of telemedicine visit convenience, completeness, and interpersonal satisfaction compared to in-person visits, and (3) use of peripheral virtual support from healthcare team, such as messaging in MyChart. After the interview has been conducted, the patient will be asked complete the patient-reported portion of the Geriatric Assessment (GA) either through an internet link, or verbally with the research staff reading the questions and recording the answers. Data pertaining to the participant's breast cancer diagnosis and treatment will be extracted from Epic@UNC.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center, School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- female
- age 65 or older
- diagnosed with early breast cancer (Stage I-III)
- completed primary treatment (surgery, chemotherapy, radiation treatment)
- received in-person outpatient care at North Caroline Cancer Hospital before transitioning to telemedicine after March 2020
- providing written informed consent
- able to understand and speak English.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria stated above will be excluded. There will be no further exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Video Telemedicine
20 participants will have used video telemedicine for appointments with their treating oncologist.
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Patients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine.
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Telephone Telemedicine
10 participants will have used telephone telemedicine for appointments with their treating oncologist.
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Patients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Summaries of Interviews about Participant Experience with Telemedicine
Time Frame: 3 months post study start
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Qualitative Summaries derived from content analysis of semi-structured interview transcripts around themes and sub themes of convenience, psychosocial experience, baseline comfort with technology, preference for telephone vs. video visits, and desire to continue using telemedicine in the future.
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3 months post study start
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Collaborators and Investigators
Investigators
- Principal Investigator: Caroline R Buse, MM, BA, BM, UNC School of Medicine Student
Publications and helpful links
General Publications
- 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.
- Eberly LA, Kallan MJ, Julien HM, Haynes N, Khatana SAM, Nathan AS, Snider C, Chokshi NP, Eneanya ND, Takvorian SU, Anastos-Wallen R, Chaiyachati K, Ambrose M, O'Quinn R, Seigerman M, Goldberg LR, Leri D, Choi K, Gitelman Y, Kolansky DM, Cappola TP, Ferrari VA, Hanson CW, Deleener ME, Adusumalli S. Patient Characteristics Associated With Telemedicine Access for Primary and Specialty Ambulatory Care During the COVID-19 Pandemic. JAMA Netw Open. 2020 Dec 1;3(12):e2031640. doi: 10.1001/jamanetworkopen.2020.31640. Erratum In: JAMA Netw Open. 2021 Feb 1;4(2):e211913.
- Narasimha S, Madathil KC, Agnisarman S, Rogers H, Welch B, Ashok A, Nair A, McElligott J. Designing Telemedicine Systems for Geriatric Patients: A Review of the Usability Studies. Telemed J E Health. 2017 Jun;23(6):459-472. doi: 10.1089/tmj.2016.0178. Epub 2016 Nov 22.
- Rowland JH, Bellizzi KM. Cancer survivorship issues: life after treatment and implications for an aging population. J Clin Oncol. 2014 Aug 20;32(24):2662-8. doi: 10.1200/JCO.2014.55.8361. Epub 2014 Jul 28.
Helpful Links
- Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, HR 6074, 116th Cong (2020)
- Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
- Final Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021 (December 1, 2020).
- Pew Research Center: Tech Adoption Climbs Among Older Adults
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC2105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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