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

750 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.

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 data supports the effectiveness of the treatment Enhanced Outpatient Symptom Management with Telemedicine and Remote Monitoring for cancer patients?

Research shows that remote monitoring tools and telemedicine can help manage symptoms in cancer patients, potentially reducing unplanned hospital visits and improving quality of life. Studies have found that telemedicine, including videoconferencing, is effective in outpatient care for cancer patients, and remote symptom management can optimize self-care and healthcare use during chemotherapy. ^{1 2 3 4 5}

Is the Enhanced Symptom Management for Cancer treatment safe for humans?

The treatment, which involves remote monitoring and telemedicine, has been used in cancer care to manage symptoms and improve patient outcomes. It has shown benefits in economic and survival outcomes, suggesting it is generally safe for use in humans. ^{3 6 7 8 9}

How is the Enhanced Outpatient Symptom Management with Telemedicine and Remote Monitoring treatment different from other cancer treatments?

This treatment is unique because it uses telemedicine and remote monitoring to manage cancer symptoms, allowing patients to receive care at home and reducing the need for emergency visits. It focuses on real-time symptom tracking and personalized support, which can improve quality of life and treatment compliance. ^{3 4 10 11 12}

Research Team

Ryan W Huey, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer. [2022]

2. England 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. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The assessment of telemedicine to support outpatient palliative care in advanced cancer. [2015]

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

Efficacy of Telemedicine Using Videoconferencing Systems in Outpatient Care for Patients With Cancer: A Systematic Review and Meta-Analysis. [2023]

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

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

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

Remote Oncology Care: Review of Current Technology and Future Directions. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors. [2021]

9. England 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. [2022]

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

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. [2021]

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

Electronic Patient Symptom Management Program to Support Patients Receiving Cancer Treatment at Home During the COVID-19 Pandemic. [2022]

12. 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]