Voice-Assisted Symptom Monitoring for Gastrointestinal Cancer

(RECOVER Trial)

Recruiting at 1 trial location

Overseen By Crisanto Macaraeg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Informed consent, Life expectancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

281 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help patients manage symptoms at home after gastrointestinal cancer surgery using the Voice-Assisted Remote Symptom Monitoring System (VARSMS). The goal is to determine if this system can smooth the recovery process by enabling patients to report symptoms daily through a device. The trial includes two groups: one will use the voice-assisted system, while the other will not engage in research-specific activities until an exit interview 40 days post-surgery. The trial seeks participants scheduled for GI surgery to remove a tumor, who can speak and understand English well, and have reliable Wi-Fi access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgery care for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Voice-Assisted Remote Symptom Monitoring System (VARSMS) is safe for post-discharge care in gastrointestinal cancer patients?

Research shows that remote symptom monitoring systems, like the one under testing, are generally safe for patients. Similar systems have been used in cancer care without causing harm. For instance, a study on another remote monitoring system found it helped reduce hospital visits for cancer patients. These systems can also improve recovery and lower complications after cancer surgery. This evidence suggests that the Voice-Assisted Remote Symptom Monitoring System (VARSMS) should be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Voice-Assisted Remote Symptom Monitoring System (VARSMS) because it offers a new way to track symptoms for gastrointestinal cancer patients right from their homes. Unlike traditional follow-up care, which often relies on in-person visits and patient-initiated communication, VARSMS uses voice technology to prompt daily check-ins, making it easier for patients to report symptoms consistently. This system aims to provide more timely and accurate symptom data, potentially leading to quicker interventions and better patient outcomes.

What evidence suggests that the Voice-Assisted Remote Symptom Monitoring System (VARSMS) is effective for post-discharge care in gastrointestinal cancer patients?

Research has shown that voice-assisted systems can help patients manage their symptoms more effectively. In a study with 112 cancer patients, those using a similar system reported better control over chemotherapy symptoms. Another study found that remote symptom monitoring reduced hospital visits for cancer patients, offering a significant advantage. A review of several studies demonstrated that these systems can greatly improve patients' quality of life. In this trial, participants in the Voice-Assisted Remote Symptom Monitoring System (VARSMS) group will use such a system after surgery for gastrointestinal cancer, which might help them feel better and reduce the need for additional hospital visits. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are fluent in English and scheduled for malignant gastrointestinal tumor resection. They must have continuous wi-fi access to participate, as the study involves a Voice-Assisted Remote Symptom Monitoring System.

Inclusion Criteria

You can consistently and continuously connect to the internet during the study.

I am scheduled for surgery to remove a cancerous tumor in my digestive system at a participating hospital.

You can speak and write in English fluently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Discharge Monitoring

Participants in the VARSMS group use a Voice-Assisted Remote Symptom Monitoring System to report symptoms daily for 40 days post-discharge.

40 days

Daily remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the monitoring period, including an exit interview.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Voice-Assisted Remote Symptom Monitoring System (VARSMS)

Trial Overview The study tests a Voice-Assisted Remote Symptom Monitoring System (VARSMS) designed to improve care after patients leave the hospital following surgery for gastrointestinal cancer.

How Is the Trial Designed?

Group I: Voice-Assisted Remote Symptom Monitoring System (VARSMS) group Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Published Research Related to This Trial

A survey of 416 cancer patients showed that 95% had access to touch-tone telephone service, while 46% had Internet access, indicating that most patients can use technology for symptom reporting.

Patients preferred using touch-tone telephones (70%) over the Internet (28%) for reporting symptoms, suggesting that technology-based reporting could improve symptom detection in cancer care, especially in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to communication technologies in a sample of cancer patients: an urban and rural survey. Abdullah, M., Theobald, DE., Butler, D., et al.[2022]

The mobile phone-based Advanced Symptom Management System (ASyMS) significantly reduced reports of fatigue and hand-foot syndrome in patients undergoing chemotherapy compared to a control group, indicating its efficacy in symptom management.

In a randomized controlled trial involving 112 cancer patients, those using ASyMS reported better management of chemotherapy-related symptoms, suggesting that remote monitoring can enhance patient care during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. Kearney, N., McCann, L., Norrie, J., et al.[2022]

The ASyMS-Can system is a new phone-based tool designed for real-time monitoring of symptoms in cancer patients undergoing chemotherapy, aiming to improve symptom management and patient care.

This Phase II feasibility study will involve 114 patients and assess various outcomes, including symptom severity and quality of life, to determine the effectiveness and acceptability of the ASyMS-Can system compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol. Moradian, S., Krzyzanowska, M., Maguire, R., et al.[2021]

The pilot study involved 26 patients with cancer and heart failure, using the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF) via an interactive voice response system (IVRS) to monitor symptoms weekly for 3 months.

The IVRS successfully generated 107 critical alerts that allowed for timely interventions, such as medication adjustments, which helped prevent hospital readmissions and improved symptom management, indicating its potential to enhance patient care and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Symptom Management Gap in Patients With Cancer and Heart Failure Using the Interactive Voice Response System: A Pilot Study. Fadol, AP., Mendoza, TR., Lenihan, DJ., et al.[2020]

The eSMART study will involve 1108 oncology patients starting first-line chemotherapy across five European countries, aiming to evaluate the effectiveness of the ASyMS remote symptom monitoring system compared to standard care.

The primary outcome will focus on symptom burden, while secondary outcomes will assess quality of life, supportive care needs, and cost-effectiveness, addressing previous methodological weaknesses in similar studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. Maguire, R., Fox, PA., McCann, L., et al.[2019]

Out of 465 patients starting systemic cancer treatment, 51.4% expressed interest in using a remote system for daily symptom monitoring, indicating a good level of acceptance for this technology.

The system demonstrated a compliance rate of 68.8% in the first 3 weeks and 59.1% by 12 weeks, suggesting that daily monitoring is feasible; however, many patients felt their reports were not adequately utilized by healthcare providers, highlighting an area for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote System for Daily Symptom Monitoring During Systemic Anticancer Treatment: Patient Acceptance, Usability, and Compliance. Coolbrandt, A., Muylaert, K., Vandeneede, E., et al.[2022]

In a randomized controlled trial with 358 chemotherapy patients, the automated Symptom Care at Home (SCH) intervention significantly reduced overall symptom severity by an average of 3.59 points, which is about 43% less than the usual care group.

SCH participants experienced a dramatic decrease in severe (67% less) and moderate (39% less) symptom days, indicating that technology-aided remote interventions can effectively improve cancer symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. Mooney, KH., Beck, SL., Wong, B., et al.[2021]

A pilot study involving 26 patients with breast or colorectal cancer demonstrated that real-time mobile phone monitoring of symptoms during capecitabine treatment allowed for safe and effective dose adjustments, with an average dose intensity of 90% of the standard dose.

The system enabled timely management of chemotherapy side effects, as 46.2% of patients experienced moderate to severe toxicity, and both patients and healthcare professionals reported feeling reassured by the monitoring process, especially during off-hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes. Weaver, A., Love, SB., Larsen, M., et al.[2022]

A remote symptom monitoring intervention was successfully adapted for real-world use in two cancer centers, focusing on core components like electronic surveys, patient education, and real-time monitoring of symptoms.

Pilot studies revealed that while most patients completed over 50% of surveys, adaptations were necessary to overcome challenges such as workflow issues, technology access, and survey fatigue, highlighting the importance of addressing these barriers for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings. Rocque, GB., Dent, DN., Ingram, SA., et al.[2023]

Citations

1. withpower.com withpower.com/trial/voice-assisted-symptom-monitoring-for-gastrointestinal-cancer-0c88f

Voice-Assisted Symptom Monitoring for Gastrointestinal ... In a randomized controlled trial involving 112 cancer patients, those using ASyMS reported better management of chemotherapy-related symptoms, suggesting that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06190730

REmote Symptom COllection to improVE postopeRative Care This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

5. ascopubs.org ascopubs.org/doi/10.1200/CCI-24-00232

Patient Perspectives on Technological Barriers and ... Remote symptom monitoring (RSM) using electronic patient-reported outcomes leverages digital technologies to gather real-time information on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184978/

Patient Perspectives on Technological Barriers and ... Remote symptom monitoring (RSM) using electronic patient-reported outcomes leverages digital technologies to gather real-time information on ...

7. curetoday.com curetoday.com/view/how-can-remote-monitoring-help-patients-after-cancer-surgery-

How Can Remote Monitoring Help Patients After Cancer ... Key Takeaways · Remote monitoring with wearable devices and apps improved recovery by 6% and reduced complications in cancer surgery patients.