Technology-Enhanced Palliative Care for Advanced Cancer

Overseen By Ishwaria M. Subbiah

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Low symptom burden, Delirium, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a technology-enhanced palliative care program can improve the quality of life for patients with advanced cancer. It combines regular clinic visits and remote care (via phone or video calls) with new technology to closely monitor symptoms. The trial includes different approaches: one group receives weekly remote contact with healthcare providers, while another group receives standard symptom management. This trial suits patients with advanced solid tumors enrolled in phase I cancer trials who experience significant symptoms and have reliable phone and internet access. As an unphased trial, it offers a unique opportunity to explore innovative care methods that could enhance quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that technology-enhanced palliative care is safe for patients with advanced cancer?

Research has shown that using technology to enhance palliative care is generally safe and well-received by patients with advanced cancer. A small study found that tools like telemedicine and wearable devices improved patients' quality of life without causing major side effects. Reports from these studies indicate very few negative effects, suggesting this approach is safe for patients. This is encouraging for those considering joining a clinical trial, as the focus is on improving care rather than introducing new drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how technology-enhanced palliative care can improve life for people with advanced cancer. Unlike traditional palliative care, which usually involves in-person visits every few weeks, this approach uses regular remote contact through technology, ensuring more consistent support. This method could make patients feel more connected and supported, even from a distance. By integrating regular, technology-driven check-ins, the trial aims to provide more personalized care and potentially enhance the overall quality of life for patients and their caregivers.

What evidence suggests that technology-enhanced palliative care is effective for improving quality of life in advanced cancer patients?

Research has shown that using technology in palliative care can improve the quality of life for patients with advanced cancer. In this trial, participants will be divided into different arms to evaluate the effectiveness of technology-enhanced palliative care. One arm will receive standard symptom management, while other arms will include weekly provider-initiated remote contact, either for patients in Phase I non-immunotherapy clinical trials or Phase I immunotherapy trials. A study found that patients receiving this type of care had better control over their symptoms and felt better overall. This method combines in-person visits and remote care, including weekly check-ins, to closely monitor symptoms. It helps manage the many symptoms common in advanced cancer by using technology to provide timely support. Overall, early findings suggest that adding technology to palliative care might improve the quality of care and patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking advanced cancer patients with high symptom burden, who have internet and phone access, and are enrolled in phase I immunotherapy trials. Caregivers must also speak English and have reliable communication means. Patients or caregivers without this access or those with low symptom burden/delirium cannot participate.

Inclusion Criteria

I have been diagnosed with an advanced solid tumor.

I have severe symptoms and high distress according to the ESAS.

Caregivers with reliable telephone and internet access

Exclusion Criteria

I do not have severe confusion or disorientation.

Patients with no reliable telephone or internet access

My caregiver is not willing to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive palliative care interventions, including technology-enhanced symptom monitoring and standard care visits, over a 12-week period

12 weeks

In-person clinic visits or remote care encounters every 4 weeks, weekly remote contact

Follow-up

Participants are monitored for clinical outcomes and symptom burden at 6 months post-enrollment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Technology-Enhanced Palliative Care

Trial Overview

The study tests a technology-enhanced palliative care program that includes symptom monitoring combined with standard clinic visits and remote care (phone/video). It aims to see if this improves the quality of life for advanced cancer patients in phase I trials.

How Is the Trial Designed?

Group I: Arm III (weekly provider-initiated remote contact) Experimental Treatment 4 Interventions

Patients in Phase I non-immunotherapy clinical trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact once a week. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.

Group II: Arm II (weekly provider-initiated remote contact) Experimental Treatment 4 Interventions

Patients in Phase I immunotherapy trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact every week. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.

Group III: Arm I (standard symptom management) Active Control 3 Interventions

Patients receive standard symptom management by palliative care team once every 4 weeks for 12 weeks. Patients and caregivers also may participate in an interview with supportive care nurse over 30-45 minutes during week 8.

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

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

The Advanced Symptom Management System in Palliative Care (ASyMSp) was tested in two rural communities in Scotland, demonstrating that mobile phone technology can effectively monitor and manage symptoms for patients in advanced stages of illness.

Both patients and healthcare professionals found the ASyMSp system to be usable and acceptable, suggesting it could enhance symptom management and improve quality of care in remote areas where face-to-face contact is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of the use of a remote monitoring system in patients receiving palliative care at home. McCall, K., Keen, J., Farrer, K., et al.[2017]

The study identified 36 quality measures related to palliative cancer care, focusing on pain, dyspnea, depression, and advance care planning (ACP), highlighting a significant emphasis on ACP measures.

Most of the identified measures were unpublished and lacked testing in cancer populations, indicating a need for further research and validation to ensure their effectiveness in improving symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality measures for symptoms and advance care planning in cancer: a systematic review. Lorenz, KA., Lynn, J., Dy, S., et al.[2023]

The systematic review identified 40 operationalized and 19 non-operationalized quality measures for palliative care in cancer patients, with the most measures available for pain (12) and advance care planning (21), but very few for depression (4) and dyspnea (2).

Despite the availability of numerous measures, there is a critical need for testing these measures specifically in cancer populations, especially for pediatric cancer care, to ensure they effectively address the quality of supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer care quality measures: symptoms and end-of-life care. Lorenz, K., Lynn, J., Dy, S., et al.[2016]

A study analyzing data from 19,747 hospice/palliative care patients over three years showed significant improvements in various patient outcomes, including symptom control and family care, although pain management did not improve.

The findings indicate that systematic data collection and feedback have led to better and more consistent patient outcomes in hospice/palliative care services across Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving national hospice/palliative care service symptom outcomes systematically through point-of-care data collection, structured feedback and benchmarking. Currow, DC., Allingham, S., Yates, P., et al.[2021]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

Citations

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This study aims to identify symptom and functional indicators from Palliative Care Outcomes Collaboration (PCOC) data and develop a predictive model

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Few studies have characterized PC delivery in the outpatient setting among patients with advanced cancer within a safety-net health system.

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The main results reveal that smart technologies enhance the quality of life and efficiency of palliative care, notably telemedicine, wearable devices, and ...

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The Project ENABLE II Randomized Controlled Trial to ...

Project ENABLE II was a randomized controlled trial of a palliative care intervention compared to care as usual for persons newly diagnosed with advanced cancer ...