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TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04936243
Recruitment Status : Completed
First Posted : June 23, 2021
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Christopher Manz, MD, Dana-Farber Cancer Institute

Study Description
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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

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Patient Engagement Patient Preference Patient Satisfaction Behavioral: FOLLOW UP VISIT-TELEMEDICINE Behavioral: FOLLOW UP VISIT-FACE TO FACE Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
Actual Study Start Date : August 1, 2021
Actual Primary Completion Date : November 1, 2022
Actual Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: FOLLOW UP VISIT-TELEMEDICINE
Routine follow up care conducted remotely with video-conferencing tools
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.
 Behavioral: FOLLOW UP VISIT-FACE TO FACE
Routine follow up care conducted in person


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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:

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04936243


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Christopher Manz, MD, MSHP Dana-Farber Cancer Institute
More Information
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Responsible Party: Christopher Manz, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04936243    
Other Study ID Numbers: 21-192
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Manz, MD, Dana-Farber Cancer Institute:
Breast Cancer
Prostate Cancer
Patient Engagement
Patient Preference
Patient Satisfaction
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases