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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04990934
Other study ID # LCCC2105
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2, 2021
Est. completion date October 10, 2021

Study information

Verified date December 2021
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 10, 2021
Est. primary completion date October 10, 2021
Accepts healthy volunteers
Gender Female
Age group 65 Years to 110 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Semistructured Interview
Patients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine.

Locations

Country Name City State
United States UNC Lineberger Comprehensive Cancer Center, School of Medicine Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative Summaries of Interviews about Participant Experience with Telemedicine 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. 3 months post study start
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