Enhanced Symptom Management for Cancer

Overseen By Ryan W Huey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Investigational drugs, Phase 1 trials, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telemedicine and remote monitoring can help cancer patients manage chemotherapy side effects more effectively than usual care. The researchers aim to determine if these tools can reduce emergency room visits, improve quality of life, and prevent treatment delays. Participants will receive either standard care, standard care with remote monitoring, or standard care with remote monitoring and biometrics. Suitable candidates are those fluent in English or Spanish with thoracic or gastrointestinal cancer, starting or continuing outpatient chemotherapy, and receiving care at specific clinics in Texas. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance patient experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, especially since the trial involves outpatient chemotherapy.

What prior data suggests that enhanced outpatient symptom management with telemedicine and remote monitoring is safe?

Research has shown that using telemedicine and remote monitoring to manage symptoms in cancer patients is generally safe. A small initial study found that telemedicine through a secure online platform was both feasible and safe for patients, aiding in symptom management without causing harm.

Remote monitoring tools have reduced unexpected hospital visits, suggesting improved symptom management for patients. This method involves no new drugs or invasive treatments, often resulting in fewer safety concerns. Overall, evidence supports that telemedicine and remote monitoring for symptom management are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how telemedicine combined with remote monitoring can enhance cancer symptom management. Unlike traditional in-person care, this approach allows patients to receive oncology care from home, which can be more convenient and reduce the need for travel. Additionally, the trial is investigating the impact of remote biometric monitoring, which provides real-time data on a patient’s health, potentially leading to more personalized and timely interventions. By integrating these technologies, the trial aims to improve patient outcomes and quality of life, offering a more responsive and patient-centered approach to cancer care.

What evidence suggests that enhanced outpatient symptom management with telemedicine and remote monitoring could be effective for reducing chemotherapy-related adverse events?

This trial will compare different approaches to symptom management for cancer patients. Research has shown that telemedicine and remote monitoring, which participants in this trial may receive, can manage symptoms more effectively. These tools have been linked to fewer unexpected hospital visits and emergency room trips. In one study, patients using remote monitoring received better care and had fewer hospital stays. Additionally, telehealth methods have lessened the severity of symptoms compared to regular care. Overall, these approaches can lead to better health outcomes and a higher quality of life for cancer patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Ryan W Huey, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with metastatic cancers of the thoracic and gastrointestinal regions, starting outpatient chemotherapy at MD Anderson Cancer Center. Caregivers can participate with patient consent. Excluded are those on investigational drugs, in phase 1 trials, requiring inpatient infusion, living in institutions like prisons, or with dementia or disabilities preventing symptom reporting.

Inclusion Criteria

I am an adult with cancer in the chest or digestive system starting chemotherapy at MDACC.

I am an adult caregiver for a patient.

Patients may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers may participate only if the patient consents

Exclusion Criteria

I cannot report my symptoms due to dementia, physical disability, or neurological issues.

You are currently taking part in a study for a new medication or treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard oncology care via telemedicine, with some undergoing additional remote and biometric monitoring

3 months

Regular telemedicine visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on acute care visits and quality of life

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Outpatient Symptom Management with Telemedicine and Remote Monitoring

Trial Overview The study tests if enhanced outpatient symptom management using telemedicine and remote monitoring reduces emergency visits due to chemotherapy side effects compared to usual care. It aims for better patient outcomes including quality of life and fewer treatment delays.

How Is the Trial Designed?

Group I: Arm III (standard of care, remote monitoring, biometrics) Experimental Treatment 3 Interventions

Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.

Group II: Arm II (standard of care, remote monitoring) Experimental Treatment 3 Interventions

Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Group III: Arm I (standard of care) Active Control 2 Interventions

Patients receive standard of care consisting of oncology care provided via telemedicine.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A prototype web-based tool was developed to help manage chemotherapy-related symptoms, based on user feedback from 14 patients, 1 caregiver, and 12 healthcare providers, highlighting the need for better communication and decision aids in cancer care.

Usability testing with 22 participants showed positive feedback for the tool's features like toxicity tracking and self-management advice, but also revealed challenges in integrating the tool into existing healthcare workflows and ensuring patient privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients. Prince, RM., Soung Yee, A., Parente, L., et al.[2020]

This Phase 3 trial will evaluate a novel nurse-led Telehealth intervention for monitoring chemotherapy side effects in 222 Australian patients with haematological cancers, aiming to improve patient outcomes and reduce hospital admissions.

The intervention involves real-time patient-reported data collection via a tablet, allowing for early detection of side effects like nausea and fatigue, which could enhance safety and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Patient Remote Intervention and Symptom Management System (PRISMS) - a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial. Breen, S., Ritchie, D., Schofield, P., 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]

In a study of 108 outpatients with advanced cancers, standardized pain education combined with telemonitoring significantly reduced pain intensity, anxiety, and depression after one week, indicating its effectiveness in managing symptoms.

The telemonitoring group showed a greater improvement in pain levels, particularly for patients experiencing higher pain scores, suggesting that this approach enhances pain management in outpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors. Kim, HS., Shin, SJ., Kim, SC., et al.[2021]

Telemedicine significantly improved access to healthcare for 12 patients with advanced cancer, allowing for effective remote monitoring and management of symptoms through various communication methods, including web conferences and phone calls.

Patients reported lower distress symptom scores during web conferences compared to in-person consultations, indicating that telemedicine can enhance symptom assessment and control, ultimately reducing the need for emergency services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment of telemedicine to support outpatient palliative care in advanced cancer. Hennemann-Krause, L., Lopes, AJ., Araújo, JA., et al.[2015]

Cancer patients often face complications from their disease and treatments, which can lead to a lower quality of life and increased hospital visits, especially during the COVID-19 pandemic.

Remote patient monitoring systems for cancer care have shown promise in improving economic and survival outcomes, suggesting that reliable devices could help track patient symptoms and health without the risks associated with in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Oncology Care: Review of Current Technology and Future Directions. McGregor, BA., Vidal, GA., Shah, SA., et al.[2020]

A study analyzing 102 unscheduled phone calls to a cancer pain clinic found that 74% of calls were made by patients or caregivers, primarily to report symptoms or treatment concerns, with pain being the most common issue reported (59.6%).

The cancer pain nurse effectively managed 87.3% of these calls without needing a doctor, providing interventions that included treatment adjustments and patient education, highlighting the importance of telephone consultations in improving patient care and reducing unnecessary emergency department visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. Remy, C., Borniard, J., Perez, J.[2021]

The electronic patient symptom management program was feasible and well-accepted during the COVID-19 pandemic, with 282 patients completing 88% of assigned surveys, indicating strong engagement.

Over half of the patients (54%) reported severe symptoms that triggered immediate provider notifications, leading to effective self-management instructions and follow-up calls that helped resolve or reduce symptom severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Patient Symptom Management Program to Support Patients Receiving Cancer Treatment at Home During the COVID-19 Pandemic. Wujcik, D., Dudley, WN., Dudley, M., et al.[2022]

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]

In a study involving 864 oncology patients, only 39% of those with severe symptoms were receptive to a remote nurse-led symptom care management phone call, indicating a significant gap in patient engagement with supportive care interventions.

The study found that patients were more likely to accept the call if they were in an opt-out system, receiving care at a tertiary center, or experiencing severe pain, suggesting that these factors could influence the effectiveness of symptom-focused interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer. Wintheiser, GA., Ruddy, KJ., Herrin, J., et al.[2022]

A pilot study involving 77 women undergoing chemotherapy for early stage breast cancer showed that a telephone symptom management intervention was feasible and well-received, with 83.8% of scheduled calls delivered.

Patients receiving the intervention had significantly fewer emergency department visits compared to controls, indicating that proactive symptom management may help reduce acute care utilization during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Toxicity Management (AToM) Pilot: results of a pilot study of a pro-active, telephone-based intervention to improve toxicity management during chemotherapy for breast cancer. Krzyzanowska, MK., MacKay, C., Han, H., et al.[2022]

Telemedicine (TM) using videoconferencing for outpatient cancer care shows no significant differences in patient satisfaction or attendance compared to traditional face-to-face care, based on a systematic review of six randomized controlled trials involving 2,400 articles.

The evidence suggests that TM can be as effective as in-person visits, indicating it may be a beneficial option for cancer patients, although the certainty of the evidence is low for many outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telemedicine Using Videoconferencing Systems in Outpatient Care for Patients With Cancer: A Systematic Review and Meta-Analysis. Uemoto, Y., Yamanaka, T., Kataoka, Y., et al.[2023]

Citations

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Enhanced Outpatient Symptom Management to Reduce ... Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better ...

2. withpower.com withpower.com/trial/phase-neoplasms-4-2021-c446c

Enhanced Symptom Management for Cancer Research shows that remote monitoring tools and telemedicine can help manage symptoms in cancer patients, potentially reducing unplanned hospital visits and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9008678/

Nurse-led telehealth interventions for symptom management ... Compared to usual care, patients exposed to telehealth interventions had reduced symptom severity and no difference in health services use.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05038254/enhanced-outpatient-symptom-management-to-reduce-acute-care-visits-due-to-chemotherapy-related-adverse-events

Enhanced Outpatient Symptom Management to Reduce ... Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and ...

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.23.00182

Impact of Remote Symptom Monitoring With Electronic ... Symptom monitoring with ePROs improved quality and value of cancer care delivery by reducing hospitalizations, emergency visits, and deaths while lowering cost ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05038254

Enhanced Outpatient Symptom Management to Reduce ... Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404616/

Safety and Efficacy of Telemedicine for Patients With ... This pilot study showed that TM interventions delivered through a secure online platform were feasible, successful, and safe. They also led to ...

8. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076251384220

Effect of remote patient monitoring on healthcare use ... This systematic review aims to assess whether RPM use among cancer patients reduces hospitalizations and length of stay (LOS).