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TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Primary Purpose

Breast Cancer, Prostate Cancer, Patient Engagement

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FOLLOW UP VISIT-TELEMEDICINE

FOLLOW UP VISIT-FACE TO FACE

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Brigham and Women's Hospital
Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

FOLLOW UP VISIT-TELEMEDICINE

FOLLOW UP VISIT-FACE TO FACE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient preference Comparison

Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care

Indirect Health Care Costs Comparison

Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:

Health system use Comparison

Compare participant health system use relating to cancer diagnosis within two weeks after study visit

Clinician Experience Comparison

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

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

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

Full Information

NCT ID

NCT04936243

First Posted

June 18, 2021

Last Updated

December 19, 2022

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04936243

Brief Title

TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Official Title

A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction

Keywords

Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLLOW UP VISIT-TELEMEDICINE

Arm Type

Experimental

Arm Description

Arm Title

FOLLOW UP VISIT-FACE TO FACE

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

FOLLOW UP VISIT-TELEMEDICINE

Intervention Description

Routine follow up care conducted remotely with video-conferencing tools

Intervention Type

Behavioral

Intervention Name(s)

FOLLOW UP VISIT-FACE TO FACE

Intervention Description

Routine follow up care conducted in person

Primary Outcome Measure Information:

Title

Patient Experience Comparison

Description

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

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Patient preference Comparison

Description

Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care

Time Frame

Up to 6 months

Title

Indirect Health Care Costs Comparison

Description

Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:

Time Frame

Up to 6 months

Title

Health system use Comparison

Description

Compare participant health system use relating to cancer diagnosis within two weeks after study visit

Time Frame

Two weeks after study visit

Title

Clinician Experience Comparison

Description

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

Time Frame

Up to 6 months

Title

Clinician Preference

Description

Time Frame

Up to 6 months

Title

Symptom severity-prostate cancer patients Comparison

Description

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

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Manz, MD, MSHP

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

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