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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The Carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, GI or multiple myeloma. For this study, a core set of variables is collected on each patient in the Carevive platform. Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic Patient Reported Outcome surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.

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 data supports the effectiveness of the treatment Remote Symptom Monitoring for cancer?

Research shows that remote symptom monitoring tools can help manage symptoms in cancer patients, potentially improving their quality of life and reducing unplanned hospital visits. Studies have indicated that these tools can decrease the severity and distress of chemotherapy-related symptoms. ^{1 2 3 4 5}

Is remote symptom monitoring safe for cancer patients?

Remote symptom monitoring has been used safely in cancer patients to manage symptoms during treatment, with studies showing it can help reduce symptom severity and improve quality of life. ^{1 3 4 6 7}

How is remote symptom monitoring for cancer different from other treatments?

Remote symptom monitoring for cancer is unique because it uses electronic systems to track symptoms in real-time, allowing for timely interventions and potentially reducing hospital visits. This approach focuses on managing symptoms through technology rather than traditional in-person methods, aiming to improve patients' quality of life and reduce treatment-related complications. ^{1 3 4 6 7}

Research Team

Aaron Galaznik, MD

Principal Investigator

Carevive Systems, Inc.

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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 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]

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 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]

References

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

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

2. 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]

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. 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]

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

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]