Technology-Enhanced Palliative Care for Advanced Cancer Patients
2 other identifiers
interventional
119
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2020
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2026
CompletedOctober 14, 2025
October 1, 2025
5.7 years
October 7, 2020
October 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in global distress score (GDS)
Will consist of paired t-tests for the global distress score (GDS, calculated as a sum of 9 physical and psychosocial ESAS items, scored from 0-90 in which a range over 35 indicates high distress) between baseline and 2 weeks if the Edmonton Symptom Assessment Scale (ESAS) scores are approximately normally distributed. If the data are clearly not normally distributed will conduct Wilcoxon signed rank tests.
Baseline to 2 weeks
Secondary Outcomes (3)
Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).
At 6 months after enrollment
Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).
At 6 months after enrollment
Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention
Up to 12 weeks on phase I trial
Study Arms (3)
Arm I (standard symptom management)
ACTIVE COMPARATORPatients 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.
Arm II (weekly provider-initiated remote contact)
EXPERIMENTALPatients 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.
Arm III (weekly provider-initiated remote contact)
EXPERIMENTALPatients 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.
Interventions
Participate in interview
Receive standard symptom management by palliative care team
Ancillary studies
Complete questionnaire
Eligibility Criteria
You may qualify if:
- PATIENT: Diagnosis of advanced solid tumor
- PATIENT: Oncologic plan for a phase I trial
- PATIENT: High symptom burden (defined as a score of \>= 4 on at least 1 Edmonton Symptom Assessment Scale \[ESAS\] symptom, AND a global distress score \[GDS\] of \>= 20)
- PATIENT: Reliable telephone and internet access
- PATIENT: Able to communicate verbally in English and provide informed consent
- CAREGIVER: Able to communicate verbally in English and provide informed consent
- CAREGIVER: Reliable telephone and internet access
You may not qualify if:
- PATIENT: Low symptom burden defined as scores \< 4 on all ESAS symptoms OR GDS \< 20
- PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale \> 8)
- PATIENT: No reliable telephone or internet access
- CAREGIVER: Refusal to participate in this study
- CAREGIVER: No reliable telephone or internet access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hui
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
August 4, 2021
Study Start
August 20, 2020
Primary Completion
May 7, 2026
Study Completion
May 7, 2026
Last Updated
October 14, 2025
Record last verified: 2025-10