Stem Cell Transplant PatientsNCT01324427
Telemedicine Evaluation for Stem Cell Transplant Patients
A study testing virtual medical visit in people with Stem Cell Transplant Patients, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's visits or examinations. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Stem Cell Transplant Patients
- What is being tested?
- virtual medical visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Aug 2020
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent or are planning to undergo a hematopoietic progenitor cell transplantation for any disease.
- Participants must be able to read and understand English*
- Age over 18 years of age since this pilot trial is only being performed in the Adult BMT Service Non-English speaking patients have been excluded in this pilot study because we do not have the support for translation services at this time. Additionally, the telemedicine instruments being used are not yet validated across all languages.
- Potential patients will be identified according to their medical condition, type and complexity of stem cell transplant procedure performed, and distance from MSKCC.
- The patients should:
- minimal comorbidities,
- be less than 75 years of age. These characteristics have been associated with good understanding and acceptance of telemedicine in other pilot trials. These characteristics will be assessed by the clinician.
- Please note: Patients on other therapeutic protocols will be eligible for this protocol as well.
Who cannot join
- Medically unstable patient as deemed by the treating team.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
About this study
Official title: Pilot Trial of Telemedicine Evaluation for Stem Cell Transplant Patients
Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's visits or examinations. This new area of health care is important to test because it can potentially provide real-time interactions between the patient and their health care team, including phone conversations, online communication, and/or home visits. Many activities such as a history review or physical examination can be conducted virtually as compared to the traditional face-to face visits.
The purpose of this study is to determine patient and health care team acceptance of a "virtual medical visit" as a substitute for a "face to face" visit for patients either preparing to receive a stem cell transplant or previously received a stem cell transplant.
- Conditions
- Stem Cell Transplant Patients
- Being tested
- virtual medical visit
- Keywords
- Telemedicine, Virtual Medical Visit, Quality of Life, 11-022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual medical visitBehavioural
At the pre-set time, the "Mobile Telehealth Cart" will be set up in the exam room or the clinic office, and a connection with the doctor will be made through their computer. The telemedicine visit will be conducted at the same time as the regular clinic visit. During the visit, the nurse will evaluate the physical symptoms, vital signs, past medical history, present medical history, and any side effects from the autologous or allogeneic transplant. The nurse will place a digital stethoscope on the chest to listen to the heart and lungs. The "virtual medical visit" will take about 25 minutes. At the end of the "Virtual Medical Visit," the patient will evaluate the event using a survey to assess the acceptance of the virtual visit. The surveys will be written and should take around 15 minutes to complete. The answers provided will be shared with the MD and nurses after the patient has completed all their "virtual medical visits."
| Study group | Role | What they receive |
|---|---|---|
| virtual medical visit | Experimental | This is a pilot trial involving a maximum of 84 patients undergoing either allogeneic or autologous stem cell transplant aimed at determining the feasibility and acceptance of a "virtual medical visit" by patients and health care personnel. During this pilot trial we expect to perform 84 "virtual medical visits" using telemedicine. Receives: Behavioral: virtual medical visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine patient & physician acceptance of a "virtual medical visit" as a substitute for a "face to face" in pts in different settings. This is assessed by analyzing answers to questions 7 & 8 of the Patient Satisfaction Survey. [Question #7: I would
Question #8: Overall, I was very satisfied with today's telemedicine session.]Physician acceptance will be analyzed looking at the answers to question 19 of the Physician/Nurse survey in which the physician or nurse investigator relates the quality of the telemedicine visit. [Question #19: How would you rate the quality of the Telehealth visit to assess the patient compared to an in-person office visit?]
Measured: 2 years
Secondary outcomes (3)
Confirm that current telemedicine technology a comprehensive stem cell transplant clinical evaluation can be performed.
Questions 1-12 of the healthcare provider survey will assess the quality of the information \&assessment collected through the "virtual medical visit".
Measured: 2 years
Evaluate the feasibility of telemedicine facilitated "handoffs" between the inpatient and the outpatient service at the time of discharge from the inpatient service and at the time of discharge from the transplant center are feasible and useful.
The instrument used to analyze the feasibility and utility of the handoff instrument is Provider Satisfaction Survey with Handoff Instrument Survey for Feedback on Handoff Instrument. We will collate these responses to determine whether the handoff instrument was found to be useful and what elements should be modified, removed or added.
Measured: 2 years
Describe the logistic characteristics of a "virtual medical visit" performed using telemedicine such as visit times, connection quality, and quality of the clinical information obtained.
The time from the first attempt to connect until the time to disconnect will be captured for all encounters as well as the time from the beginning to end of the "virtual medical visit". We expect that the "virtual medical visit" should take on average 20 minutes from attempt to connect to disconnect.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Giralt, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324427
- Sponsor's protocol ID
- 11-022
- Status last verified
- Aug 2020
- First submitted
- 24 Mar 2011
- Last updated
- 14 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Telemedicine Evaluation for Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT01324427
- Acronym / sponsor ID
- 11-022
- Conditions
- Stem Cell Transplant Patients
- Keywords
- Telemedicine, Virtual Medical Visit, Quality of Life, 11-022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 Mar 2011 (estimated)
- 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.
Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's visits or examinations. This new area of health care is important to test because it can potentially provide real-time interactions between the patient and their health care team, including phone conversations, online communication, and/or home visits. Many activities such as a history review or physical examination can be conducted virtually as compared to the traditional face-to face visits.
The purpose of this study is to determine patient and health care team acceptance of a "virtual medical visit" as a substitute for a "face to face" visit for patients either preparing to receive a stem cell transplant or previously received a stem cell transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual medical visit | Experimental | Behavioral: virtual medical visitThis is a pilot trial involving a maximum of 84 patients undergoing either allogeneic or autologous stem cell transplant aimed at determining the feasibility and acceptance of a "virtual medical visit" by patients and health care personnel. During this pilot trial we expect to perform 84 "virtual medical visits" using telemedicine. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who underwent or are planning to undergo a hematopoietic progenitor cell transplantation for any disease.
- Participants must be able to read and understand English*
- Age over 18 years of age since this pilot trial is only being performed in the Adult BMT Service Non-English speaking patients have been excluded in this pilot study because we do not have the support for translation services at this time. Additionally, the telemedicine instruments being used are not yet validated across all languages.
- Potential patients will be identified according to their medical condition, type and complexity of stem cell transplant procedure performed, and distance from MSKCC.
- minimal comorbidities,
Key exclusion criteria (1 listed)
- Medically unstable patient as deemed by the treating team.
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 |
|---|---|---|
| virtual medical visitAt the pre-set time, the "Mobile Telehealth Cart" will be set up in the exam room or the clinic office, and a connection with the doctor will be made through their computer. The telemedicine visit will be conducted at the same time as the regular clinic visit. During the visit, the nurse will evaluate the physical symptoms, vital signs, past medical history, present medical history, and any side effects from the autologous or allogeneic transplant. The nurse will place a digital stethoscope on the chest to listen to the heart and lungs. The "virtual medical visit" will take about 25 minutes. At the end of the "Virtual Medical Visit," the patient will evaluate the event using a survey to assess the acceptance of the virtual visit. The surveys will be written and should take around 15 minutes to complete. The answers provided will be shared with the MD and nurses after the patient has completed all their "virtual medical visits." | Behavioural | virtual medical visit |
Primary outcome
Determine patient & physician acceptance of a "virtual medical visit" as a substitute for a "face to face" in pts in different settings. This is assessed by analyzing answers to questions 7 & 8 of the Patient Satisfaction Survey. [Question #7: I would
Time frame: 2 years
Question #8: Overall, I was very satisfied with today's telemedicine session.]Physician acceptance will be analyzed looking at the answers to question 19 of the Physician/Nurse survey in which the physician or nurse investigator relates the quality of the telemedicine visit. [Question #19: How would you rate the quality of the Telehealth visit to assess the patient compared to an in-person office visit?]
3 secondary outcomes
Confirm that current telemedicine technology a comprehensive stem cell transplant clinical evaluation can be performed.
Time frame: 2 years
Evaluate the feasibility of telemedicine facilitated "handoffs" between the inpatient and the outpatient service at the time of discharge from the inpatient service and at the time of discharge from the transplant center are feasible and useful.
Time frame: 2 years
Describe the logistic characteristics of a "virtual medical visit" performed using telemedicine such as visit times, connection quality, and quality of the clinical information obtained.
Time frame: 2 years
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 14 Aug 2020.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Sergio Giralt, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual medical visit in people with Stem Cell Transplant Patients, run by Memorial Sloan Kettering Cancer Center at 4 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 1 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Determine patient & physician acceptance of a "virtual medical visit" as a substitute for a "face to face" in pts in different settings. This is assessed by analyzing answers to questions 7 & 8 of the Patient Satisfaction Survey. [Question #7: I would (time frame: 2 years). 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 14 Aug 2020.