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Technology-Enhanced Palliative Care for Advanced Cancer

N/A
Waitlist Available
Led By Ishwaria M Subbiah
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregivers able to communicate verbally in English and provide informed consent
Patients with a diagnosis of advanced solid tumor
Must not have
Patients with delirium (i.e. Memorial Delirium Assessment Scale > 8)
Caregivers who refuse to participate in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after enrollment
Awards & highlights

Summary

This trial is investigating whether technology-enhanced palliative care, when combined with in-person clinic visits and standard remote care visits, can help increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve interviews, assessments, and questionnaires rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological discomfort discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak English and agree to participate.
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I have been diagnosed with an advanced solid tumor.
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I have severe symptoms and high distress according to the ESAS.
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I can speak English and understand the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe confusion or disorientation.
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My caregiver is not willing to participate in this study.
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My symptoms are mild, scoring less than 4 on all ESAS symptoms or my depression score is below 20.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in global distress score (GDS)
Secondary outcome measures
Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).
Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).
Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (weekly provider-initiated remote contact)Experimental Treatment4 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 Treatment4 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 Control3 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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,160 Total Patients Enrolled
Ishwaria M SubbiahPrincipal InvestigatorM.D. Anderson Cancer Center
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,822 Total Patients Enrolled
~24 spots leftby Jul 2025
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