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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Voice-Assisted Remote Symptom Monitoring System (VARSMS) for gastrointestinal cancer?

Research on similar remote symptom monitoring systems, like the Symptom Care at Home (SCH) intervention, shows that these systems can reduce the severity of symptoms in cancer patients undergoing chemotherapy. Additionally, the Interactive Voice Response System (IVRS) has been effective in managing symptoms for patients with cancer and heart failure, suggesting that voice-assisted systems can improve symptom management and patient outcomes. ^{1 2 3 4 5}

Is voice-assisted symptom monitoring safe for humans?

Research on similar remote symptom monitoring systems, like ASyMS, used in cancer care shows they are generally safe for patients. These systems have been used to monitor symptoms during cancer treatment without significant safety concerns. ^{2 3 4 6 7}

How is the Voice-Assisted Remote Symptom Monitoring System (VARSMS) treatment different from other treatments for gastrointestinal cancer?

The Voice-Assisted Remote Symptom Monitoring System (VARSMS) is unique because it uses voice technology to monitor symptoms in real-time, allowing for immediate communication and intervention, unlike traditional treatments that may not offer such proactive and continuous monitoring. ^{3 5 7 8 9}

Eligibility Criteria

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

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

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

You can speak and write in English fluently.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Remote System for Daily Symptom Monitoring During Systemic Anticancer Treatment: Patient Acceptance, Usability, and Compliance. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings. [2023]

5. United States 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. [2020]

6. England 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. [2019]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Access to communication technologies in a sample of cancer patients: an urban and rural survey. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes. [2022]