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

119 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates technology-enhanced palliative care for patients in phase I trials with cancer that has spread to other places in the body (advanced). The goal of this study is to learn if the technology-enhanced palliative care symptom-monitoring program, when combined with in-person clinic visits and standard remote care visits (by phone or video call), helps increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.

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 data supports the effectiveness of the treatment Technology-Enhanced Palliative Care for Advanced Cancer?

Research shows that palliative care (supportive care for serious illness) improves the quality of life for patients with advanced cancer, especially when integrated early in their treatment. This suggests that technology-enhanced palliative care could also be effective in improving patient outcomes. ^{1 2 3 4 5}

Is Technology-Enhanced Palliative Care safe for humans?

In a study of six clinical trials in palliative care, 5.3% of participants experienced serious adverse events, but none were definitely linked to the treatment, and all resolved after stopping the intervention. This suggests that the treatment is generally safe for participants. ^{6 7 8 9 10}

How does the Technology-Enhanced Palliative Care treatment for advanced cancer differ from other treatments?

This treatment is unique because it uses technology, such as virtual visits and remote monitoring systems, to enhance palliative care for advanced cancer patients, especially those in rural or isolated areas. It allows for real-time symptom reporting and management, improving accessibility and quality of care compared to traditional face-to-face methods. ^{1 11 12 13 14}

Research Team

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 can speak English and agree to participate.

I have been diagnosed with an advanced solid tumor.

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

Exclusion Criteria

I do not have severe confusion or disorientation.

Patients with no reliable telephone or internet access

Caregivers with no reliable telephone or internet access

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

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

Improvements in Patient and Health System Outcomes Using an Integrated Oncology and Palliative Medicine Approach on a Solid Tumor Inpatient Service. [2018]

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

Quality measures for symptoms and advance care planning in cancer: a systematic review. [2023]

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

Cancer care quality measures: symptoms and end-of-life care. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Improving national hospice/palliative care service symptom outcomes systematically through point-of-care data collection, structured feedback and benchmarking. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Mixed-methods study protocol: do national reporting and learning system medication incidents in palliative care reflect patient and carer concerns about medication management and safety? [2023]

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

Participant Safety in Multisite, Randomized, Double-Blind, Placebo-Controlled Clinical Trials in Hospice/Palliative Care: Data from the Contracted Studies of the Australian National Palliative Care Clinical Studies Collaborative. [2023]

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

Electronic patient-reported outcomes (e-PROMs) in palliative cancer care: a scoping review. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer patient-reported outcomes assessment using wireless touch screen tablet computers. [2022]

10. England 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Information and communication technology for managing pain in palliative care: a review of the literature. [2022]

12. Egypt pubmed.ncbi.nlm.nih.gov

Dignity and deferral narratives as strategies in facilitated technology-based support groups for people with advanced cancer. [2021]

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

The feasibility of using technology to enhance the transition of palliative care for rural patients. [2014]

14. England pubmed.ncbi.nlm.nih.gov

Perceptions of the use of a remote monitoring system in patients receiving palliative care at home. [2017]