Breast Cancer FemaleNCT04990934
Transitioning Care: Perspectives of Older Women With Early Breast Cancer on Current Telemedicine Modalities
An observational study of Breast Cancer Female and Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 110 years, women only
- Conditions the study is for
- Breast Cancer Female, Breast Cancer
- What is being tested?
- Semistructured Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 10 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- Women only
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet the inclusion criteria stated above will be excluded. There will be no further exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center, School of Medicine
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Breast Cancer Female, Breast Cancer
- Being tested
- Semistructured Interview
- Keywords
- Telemedicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semistructured InterviewBehavioural
Patients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine.
| Study group | Role | What they receive |
|---|---|---|
| Video Telemedicine | 20 participants will have used video telemedicine for appointments with their treating oncologist. Receives: Behavioral: Semistructured Interview | |
| Telephone Telemedicine | 10 participants will have used telephone telemedicine for appointments with their treating oncologist. Receives: Behavioral: Semistructured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start2 Jul 2021
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline R Buse, MM, BA, BM, Principal investigator, UNC School of Medicine Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990934
- Sponsor's protocol ID
- LCCC2105
- Status last verified
- Dec 2021
- First submitted
- 25 Jun 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 30231354Eberly 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.
PubMed 33372974Narasimha 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.
PubMed 27875667Rowland 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.
PubMed 25071099
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning Care: Perspectives of Older Women With Early Breast Cancer on Current Telemedicine Modalities
- ClinicalTrials.gov ID
- NCT04990934
- Acronym / sponsor ID
- LCCC2105
- Conditions
- Breast Cancer Female, Breast Cancer
- Keywords
- Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Telemedicine | – | Behavioral: Semistructured Interview20 participants will have used video telemedicine for appointments with their treating oncologist. |
| Telephone Telemedicine | – | Behavioral: Semistructured Interview10 participants will have used telephone telemedicine for appointments with their treating oncologist. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- Female only
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria stated above will be excluded. There will be no further exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semistructured InterviewPatients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine. | Behavioural | Telephone Telemedicine, Video Telemedicine |
Primary outcome
Qualitative Summaries of Interviews about Participant Experience with Telemedicine
Time frame: 3 months post study start
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 30231354Sirintrapun SJ, Lopez AM. Telemedicine in Cancer Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:540-545. doi: 10.1200/EDBK_200141.
- Background: PubMed 33372974Eberly 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.
- Background: PubMed 27875667Narasimha 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.
- Background: PubMed 25071099Rowland 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.
- Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, HR 6074, 116th Cong (2020)Link provided by the sponsor.
- Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health EmergencyLink provided by the sponsor.
- Final Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021 (December 1, 2020).Link provided by the sponsor.
- Pew Research Center: Tech Adoption Climbs Among Older AdultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline R Buse, MM, BA, BM principal investigator
UNC School of Medicine Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Summaries of Interviews about Participant Experience with Telemedicine (time frame: 3 months post study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990934, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.