NCT04990934

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

July 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

June 25, 2021

Last Update Submit

December 1, 2021

Conditions

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Video Telemedicine

20 participants will have used video telemedicine for appointments with their treating oncologist.

Behavioral: Semistructured Interview

Telephone Telemedicine

10 participants will have used telephone telemedicine for appointments with their treating oncologist.

Behavioral: Semistructured Interview

Interventions

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

Telephone TelemedicineVideo Telemedicine

Eligibility Criteria

Age65 Years - 110 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identifying women will be eligible
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with early BC (Stage I-III) who have completed primary treatment and received in-person outpatient care at North Carolina Cancer Hospital before transitioning to telemedicine after March 2020.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center, School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

  • 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: 30231354BACKGROUND
  • 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.

    PMID: 33372974BACKGROUND
  • 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.

    PMID: 27875667BACKGROUND
  • 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.

    PMID: 25071099BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Caroline R Buse, MM, BA, BM

    UNC School of Medicine Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

August 5, 2021

Study Start

July 2, 2021

Primary Completion

October 10, 2021

Study Completion

October 10, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
9 to 24 months following publication
Access Criteria
When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the UNC Office of Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data.
More information

Locations