TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)
A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
1 other identifier
interventional
30
1 country
2
Brief Summary
This research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2021
Shorter than P25 for not_applicable breast-cancer
2 active sites
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 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedDecember 20, 2022
December 1, 2022
1.3 years
June 18, 2021
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Experience Comparison
Compare early-stage breast and early stage prostate cancer patients' experiences with a one-time Telemedicine (TM) versus Face to Face (F2F) follow up visit for routine oncologic surveillance
Up to 6 months
Secondary Outcomes (6)
Patient preference Comparison
Up to 6 months
Indirect Health Care Costs Comparison
Up to 6 months
Health system use Comparison
Two weeks after study visit
Clinician Experience Comparison
Up to 6 months
Clinician Preference
Up to 6 months
- +1 more secondary outcomes
Study Arms (2)
FOLLOW UP VISIT-TELEMEDICINE
EXPERIMENTALAfter initial in-person routine followup care, participants will be randomly assigned to receive telemedicine care delivery for their subsequent follow up appointment. Participants will complete a survey after each visit.
FOLLOW UP VISIT-FACE TO FACE
EXPERIMENTALAfter initial in-person routine followup care, participants will be randomly assigned to receive face-to-face care delivery for their subsequent follow up appointment. Participants will complete a survey after each visit.
Interventions
Routine follow up care conducted remotely with video-conferencing tools
Routine follow up care conducted in person
Eligibility Criteria
You may qualify if:
- For breast cancer participants: Early-stage breast cancer defined as Stages I-IIIA at diagnosis or localized prostate cancer defined as Stages I-III
- For breast cancer participants: participant has completed definitive treatment for early stage breast cancer including surgery, radiation, chemotherapy, anti-HER2 antibody treatment. Participant may or may not be taking oral anti-estrogen treatment such as tamoxifen or an aromatase inhibitor
- For prostate cancer participants: participant is on active surveillance or has undergone definitive surgery for localized prostate cancer
- Participant is on a surveillance follow up visit schedule occurring at every three to seven month intervals
- Willingness and ability to use Patient Gateway portal
- Participant has access to an electronic device that can support a video and audio virtual visit platform (for example, laptop computer, desktop computer, smart phone)
- Participants can be women or men
- Age ≥ 18 years
You may not qualify if:
- Patients whose next visit requires cytotoxic chemotherapy, radiation therapy, anti-HER2 antibody therapy or investigational cancer agents are ineligible
- Patients with distant metastatic breast cancer
- Patients with locally advanced or metastatic prostate cancer
- Patients treated by radiation therapy for prostate cancer
- Patients whose next visit requires a prostate biopsy
- Prisoners
- Non-English speaking patients (non-English speaking patients will be excluded from the trial given the challenges of delivering telemedicine with the use of medical interpreters. There are also logistical challenges in obtaining the study endpoints, which are largely survey based, with non-English speakers as well as the possibility that study endpoints will be influenced by the presence of a medical interpreter during a visit).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Manz, MD, MSHP
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 23, 2021
Study Start
August 1, 2021
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
December 20, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.