TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

• ClinicalTrials.gov Identifier: NCT04936243
• Recruitment Status: Completed
• First Posted: June 23, 2021
• Last Update Posted: December 20, 2022
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Christopher Manz, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: June 18, 2021
• First Posted Date: June 23, 2021
• Last Update Posted Date: December 20, 2022
• Actual Study Start Date: August 1, 2021
• Actual Primary Completion Date: November 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2021)

Patient Experience Comparison [ Time Frame: Up to 6 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 18, 2021)

• Patient preference Comparison [ Time Frame: Up to 6 months ]
  Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care
• Indirect Health Care Costs Comparison [ Time Frame: Up to 6 months ]
  Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:
• Health system use Comparison [ Time Frame: Two weeks after study visit ]
  Compare participant health system use relating to cancer diagnosis within two weeks after study visit
• Clinician Experience Comparison [ Time Frame: Up to 6 months ]
  Compare the clinician experience with Telemedicine (TM) versus Face to Face (F2F) for a one-time surveillance follow up visit for breast or prostate cancer care
• Clinician Preference [ Time Frame: Up to 6 months ]
  Assessing clinician preference regarding the appropriate use of telemedicine visits for the follow-up of early stage cancer patients who have completed early active therapy (e.g., surgery, radiation and/or chemotherapy) or are under surveillance
• Symptom severity-prostate cancer patients Comparison [ Time Frame: Up to 6 months ]
  Compare patient reported erectile dysfunction and urinary symptoms after undergoing radical prostatectomy between patients who have a TM follow up visit vs. a F2F follow up visit

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)
• Official Title: A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
• 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

Detailed Description

This study is a prospective randomized trial of telemedicine (TM) versus face-to-face (F2F) visits for follow up care of patients with either early-stage breast or prostate cancer.

This study does not involve investigational drugs or devices but does involve survey data collection from participants about their experiences of care.

After an initial in-person routine visit, participants will be randomly assigned to either telemedicine or face-to-face care delivery for their next routine visit.

It is anticipated participants will be in the study for about 6 months depending on the timing of their routine care appointments.

It is expected that 360 people will take part in this research study

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Breast Cancer
• Prostate Cancer
• Patient Engagement
• Patient Preference
• Patient Satisfaction

Intervention

• Behavioral: FOLLOW UP VISIT-TELEMEDICINE
  Routine follow up care conducted remotely with video-conferencing tools
• Behavioral: FOLLOW UP VISIT-FACE TO FACE
  Routine follow up care conducted in person

Study Arms

• Experimental: FOLLOW UP VISIT-TELEMEDICINE
  After 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.
  Intervention: Behavioral: FOLLOW UP VISIT-TELEMEDICINE
• Experimental: FOLLOW UP VISIT-FACE TO FACE
  After 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.
  Intervention: Behavioral: FOLLOW UP VISIT-FACE TO FACE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2022): 30
• Original Estimated Enrollment (submitted: June 18, 2021): 360
• Actual Study Completion Date: November 1, 2022
• Actual Primary Completion Date: November 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04936243
• Other Study ID Numbers: 21-192
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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

• Current Responsible Party: Christopher Manz, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Eleni Stavrou, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christopher Manz, MD, MSHP; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: December 2022