Remote Symptom Monitoring for Cancer

Overseen By Julie Scott, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carevive Systems, Inc.

Disqualifiers: Non-English speakers, Inability to use devices, Clinical trial participants, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tracks symptoms in individuals receiving treatments for certain types of cancer, specifically breast, lung, gastrointestinal (GI), ovarian cancers, and multiple myeloma. Participants will regularly complete surveys about their symptoms and treatment experiences through an online platform for remote symptom monitoring. This trial suits those diagnosed with one of these cancers who can use a smartphone, tablet, or computer to complete surveys in English. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance symptom management for future patients.

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, as the study focuses on monitoring symptoms and treatment experiences.

What prior data suggests that this remote symptom monitoring is safe for cancer patients?

Research has shown that remote symptom monitoring is safe for people with cancer. Studies have found that this technology can reduce the need for hospital visits, indicating it is generally well-tolerated. Other research suggests that these systems offer a cost-effective way to manage cancer care, allowing patients to track side effects without in-person doctor visits. Additionally, several studies have demonstrated that remote monitoring can improve symptoms and health outcomes for patients. Overall, evidence suggests that remote symptom monitoring is a safe option for those considering this type of cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote symptom monitoring for cancer because it offers a new way to track and manage symptoms from a distance, using technology. Unlike traditional in-person visits that require time and travel, this method allows patients to report symptoms in real-time from the comfort of their homes. This could lead to quicker responses from healthcare providers and more personalized care, potentially improving patient outcomes and quality of life. By leveraging digital tools, remote monitoring can also enhance patient engagement and provide a more comprehensive view of a patient's health over time.

What evidence suggests that remote symptom monitoring is effective for cancer patients?

Research has shown that remote symptom monitoring (RSM) can greatly benefit cancer patients. One study found that RSM with electronic patient feedback reduced hospital visits. Another report indicated that 94.6% of alerts about patient symptoms improved within two weeks. Additionally, a review of several studies confirmed that RSM significantly enhanced the quality of life for lung cancer patients. Overall, these findings suggest that RSM can effectively manage symptoms and improve life for those undergoing cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron Galaznik, MD

Principal Investigator

Carevive Systems, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with breast, lung, GI cancer or multiple myeloma who can complete online surveys in English using a digital device. It's open to patients at any stage of treatment but not to those on another treatment clinical trial or unable to understand English.

Inclusion Criteria

Participants must be able to complete online surveys using a cell phone, tablet, or computer

Participants must be able to understand English

You have been diagnosed with breast, lung, GI, or ovarian cancer, or multiple myeloma.

Exclusion Criteria

Patients who cannot understand written or spoken English

Patients without the ability to complete online surveys using a cell phone, tablet, or computer

Prisoners and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey in person or remotely using a secured device

1 week

1 visit (in-person or remote)

Treatment

Weekly electronic Patient Reported Outcome surveys are collected for a minimum of 12 weeks

12 weeks

Weekly remote surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Symptom Monitoring

Trial Overview The study is collecting data through the Carevive platform on patient characteristics, symptoms, and treatment experiences via weekly surveys for at least 12 weeks while they receive cancer treatment.

Who Is Running the Clinical Trial?

Carevive Systems, Inc.

Lead Sponsor

Trials

16

Recruited

1,100+

Published Research Related to This Trial

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 use of electronic patient-reported outcome measures (ePROMs) in advanced breast cancer care, when combined with interventions from oncology clinical nurse specialists (CNSs), has been shown to enhance patient outcomes and experiences through effective remote symptom monitoring.

Oncology clinical nurse specialists play a vital role in implementing ePROMs, helping to address complex symptoms and improve the quality of life for patients with advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Patient Reported Outcome Measures for Optimal Remote Symptom Management in Advanced Breast Cancer: Embracing Digital Health Technology. Warren, M.[2023]

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 Advanced Symptom Management System (ASyMS) significantly reduced symptom burden in patients undergoing adjuvant chemotherapy, keeping their symptoms at pre-treatment levels, while those receiving standard care experienced increased symptoms throughout treatment.

Patients using ASyMS reported better quality of life and lower anxiety levels compared to the control group, indicating that remote monitoring can enhance patient support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). Maguire, R., McCann, L., Kotronoulas, G., et al.[2021]

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]

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]

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]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11496975/

Implementation of a remote symptom monitoring pathway ... The RPM pathway enabled effective and timely symptom management with 94.6% of all alerts (10,132/10,711) evolving to an improvement two weeks ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.2024.20.10_suppl.250

Trajectory of symptoms reported in remote ... Results: Of 80 patients approached, a total of 57 (71%) patients with lung cancer were enrolled in RSM; 20% were Black or African American and ...

4. accc-cancer.org accc-cancer.org/home/attend/event-template/2022/08/09/default-calendar/telehealth-success-stories-remote-symptom-monitoring-using-patient-reported-outcomes

Telehealth Success Stories: Remote Symptom Monitoring ... Multiple studies have shown that integrating remote symptom monitoring into cancer care using patient-reported outcomes (PRO) favorably impacts ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4419632/

Benefits of remote real-time side-effect monitoring systems for ... Telemedicine devices that allow for the remote, real-time monitoring of symptoms may be a cost-effective strategy to optimize cancer care in the community.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208125000944

Integrating Remote Symptom Monitoring, Person-Centered ... Several remote symptom monitoring interventions have demonstrated potential to reduce disease- and treatment-related symptom burden and improve health outcomes ...

8. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.496

Patterns in remote symptom monitoring compliance among ... 496. Background: Remote symptom monitoring (RSM) enables patients with cancer to report treatment-related symptoms in real time.

9. nature.com nature.com/articles/s41746-025-01812-x

Effectiveness of symptom monitoring on electronic patient ... Symptom monitoring using electronic patient-reported outcomes (ePROs) has demonstrated benefits for patients with cancer, yet the systematic ...