Breast CancerNCT04936243
TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)
A study testing FOLLOW UP VISIT-TELEMEDICINE and FOLLOW UP VISIT-FACE TO FACE in people with Breast Cancer and Prostate Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Patient Engagement
- What is being tested?
- FOLLOW UP VISIT-TELEMEDICINE and FOLLOW UP VISIT-FACE TO FACE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Control Trial of 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
Read the 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
- Conditions
- Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction
- Being tested
- FOLLOW UP VISIT-TELEMEDICINE, FOLLOW UP VISIT-FACE TO FACE
- Keywords
- Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Patient Participation, Patient Preference, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLLOW UP VISIT-TELEMEDICINEBehavioural
Routine follow up care conducted remotely with video-conferencing tools
FOLLOW UP VISIT-FACE TO FACEBehavioural
Routine follow up care conducted in person
| Study group | Role | What they receive |
|---|---|---|
| FOLLOW UP VISIT-TELEMEDICINE | Experimental | 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. Receives: Behavioral: FOLLOW UP VISIT-TELEMEDICINE |
| FOLLOW UP VISIT-FACE TO FACE | Experimental | 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. Receives: Behavioral: FOLLOW UP VISIT-FACE TO FACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Secondary outcomes (6)
Patient preference Comparison
Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care
Measured: Up to 6 months
Indirect Health Care Costs Comparison
Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:
Measured: Up to 6 months
Health system use Comparison
Compare participant health system use relating to cancer diagnosis within two weeks after study visit
Measured: 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
Measured: Up to 6 months
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
Measured: Up to 6 months
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Aug 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Manz, MD, Dana-Farber Cancer Institute
- Investigators
- Christopher Manz, MD, MSHP, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936243
- Sponsor's protocol ID
- 21-192
- Status last verified
- Dec 2022
- First submitted
- 18 Jun 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
- ClinicalTrials.gov ID
- NCT04936243
- Acronym / sponsor ID
- 21-192
- Conditions
- Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction
- Keywords
- Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLLOW UP VISIT-TELEMEDICINE | Experimental | Behavioral: FOLLOW UP VISIT-TELEMEDICINEAfter 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 | Experimental | Behavioral: FOLLOW UP VISIT-FACE TO FACEAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLLOW UP VISIT-TELEMEDICINERoutine follow up care conducted remotely with video-conferencing tools | Behavioural | FOLLOW UP VISIT-TELEMEDICINE |
| FOLLOW UP VISIT-FACE TO FACERoutine follow up care conducted in person | Behavioural | FOLLOW UP VISIT-FACE TO FACE |
Primary outcome
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
6 secondary outcomes
Patient preference Comparison
Time frame: Up to 6 months
Indirect Health Care Costs Comparison
Time frame: Up to 6 months
Health system use Comparison
Time frame: Two weeks after study visit
Clinician Experience Comparison
Time frame: Up to 6 months
Clinician Preference
Time frame: Up to 6 months
Symptom severity-prostate cancer patients Comparison
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Manz, MD, MSHP principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOLLOW UP VISIT-TELEMEDICINE and FOLLOW UP VISIT-FACE TO FACE in people with Breast Cancer and Prostate Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experience Comparison (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.