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Completed

NCT Number: NCT04936243

TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FOLLOW UP VISIT-TELEMEDICINE

Behavioral

Routine follow up care conducted remotely with video-conferencing tools

FOLLOW UP VISIT-FACE TO FACE

Behavioral

Routine follow up care conducted in person

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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