Gastrointestinal CancerRECOVERNCT06190730
REmote Symptom COllection to improVE postopeRative Care
A study testing Voice-Assisted Remote Symptom Monitoring System (VARSMS) in people with Gastrointestinal Cancer and Gastrointestinal Tumor, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Gastrointestinal Tumor, Gastrointestinal Tumor Surgery
- What is being tested?
- Voice-Assisted Remote Symptom Monitoring System (VARSMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years old. Ages of subjects >89 will simply be reported as >90.
- Scheduled for a GI surgery for management of a tumor in a participating hospital.
- Fluent in oral and written English.
- Has consistent and continued full access to an operational Wi-Fi for the duration of the study.
Who cannot join
- Unable to provide informed consent.
- Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
- Life expectancy of less than 60 days.
- In the opinion of the investigator, participation in this study is contraindicated.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MedStar Health
Baltimore, Maryland, 21218
- Recruiting
Creighton University
Omaha, Nebraska, 68124
About this study
There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.
Read the detailed description
Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Tumor, Gastrointestinal Tumor Surgery, Gastrointestinal Surgery
- Being tested
- Voice-Assisted Remote Symptom Monitoring System (VARSMS)
- Keywords
- speech system, large language model, ai
- Medical subject headings
- Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice-Assisted Remote Symptom Monitoring System (VARSMS)Other
Also called Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phase
Utilizing an Alexa Skill activated via an Amazon Echo Dot device, this system will administer two patient-reported outcomes measures to subjects. This will not be used as basis for diagnosis, nor for any clinical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Besides the consent process, subjects in this arm will have no other research-specific activities until after 40 days after the surgery for an exit interview. |
| Voice-Assisted Remote Symptom Monitoring System (VARSMS) group | Experimental | Subjects in this group will be issued the device, to be activated 1 day after discharge. The device will administer a set of questions daily. Receives: Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
Daily symptom-based self-reported assessment on dyspnea, fever, melena, pain, wound healing, activities of daily living, sensorium, gastrointestinal motility, dysphagia, pitting edema, mood, and an option to mention symptoms not asked of.
This is monitored by the research team, and any concerning finding, at the discretion of the site's physician, will be relayed to the subject's treating physician.
Treating physician has final decision on whether to address referral by adjustment of management.
Measured: 40 days
Secondary outcomes (1)
SASSI (Subjective Assessment of Speech System Interfaces)
After interacting with the speech system for 40 days from the day after discharge, this questionnaire assesses the patient on their experience, having them rate the system based on system response accuracy, likeability, cognitive demand, annoyance, habitability, and speed.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Jul 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
- Masking
- None (open label)
- Enrolment
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190730
- Sponsor's protocol ID
- STUDY00007172
- Acronym
- RECOVER
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote Symptom COllection to improVE postopeRative Care
- ClinicalTrials.gov ID
- NCT06190730
- Acronym / sponsor ID
- RECOVER / STUDY00007172
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Tumor, Gastrointestinal Tumor Surgery, Gastrointestinal Surgery
- Keywords
- speech system, large language model, ai
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2024 (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.
There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.
Detailed description
Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Besides the consent process, subjects in this arm will have no other research-specific activities until after 40 days after the surgery for an exit interview. |
| Voice-Assisted Remote Symptom Monitoring System (VARSMS) group | Experimental | Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS)Subjects in this group will be issued the device, to be activated 1 day after discharge. The device will administer a set of questions daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old. Ages of subjects >89 will simply be reported as >90.
- Scheduled for a GI surgery for management of a tumor in a participating hospital.
- Fluent in oral and written English.
- Has consistent and continued full access to an operational Wi-Fi for the duration of the study.
Key exclusion criteria (4 listed)
- Unable to provide informed consent.
- Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
- Life expectancy of less than 60 days.
- In the opinion of the investigator, participation in this study is contraindicated.
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 |
|---|---|---|
| Voice-Assisted Remote Symptom Monitoring System (VARSMS)Also: Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phaseUtilizing an Alexa Skill activated via an Amazon Echo Dot device, this system will administer two patient-reported outcomes measures to subjects. This will not be used as basis for diagnosis, nor for any clinical intervention. | Other | Voice-Assisted Remote Symptom Monitoring System (VARSMS) group |
Primary outcome
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
Time frame: 40 days
Daily symptom-based self-reported assessment on dyspnea, fever, melena, pain, wound healing, activities of daily living, sensorium, gastrointestinal motility, dysphagia, pitting edema, mood, and an option to mention symptoms not asked of. This is monitored by the research team, and any concerning finding, at the discretion of the site's physician, will be relayed to the subject's treating physician. Treating physician has final decision on whether to address referral by adjustment of management.
1 secondary outcome
SASSI (Subjective Assessment of Speech System Interfaces)
Time frame: 40 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice-Assisted Remote Symptom Monitoring System (VARSMS) in people with Gastrointestinal Cancer and Gastrointestinal Tumor, run by Medstar Health Research 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nawar Shara, PhD (301-502-0339, nawar.shara@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) (time frame: 40 days). 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 3 Apr 2025.