Advanced Cancer Clinical Trial
Official title:
Developing and Testing a Web-based Tool to Engage Advanced Cancer Patients in Palliative Care (ēlos)
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls.
The investigators will conduct a prospective cohort study to investigate usability of
implementing Ēlos across 50 advanced cancer patients within the Duke Cancer Institute and
University of North Carolina - Chapel Hill Cancer Center. The investigators will obtain a
Data Transfer Agreement prior to enrollment at the University of North Carolina. Usability
testing evaluates a technology system's capacity for practical implementation in the field
including logistical, social, financial, regulatory, and time considerations. The Usability
test will also build foundational data needed to design a future, multi-site controlled trial
evaluating the efficacy of Ēlos alongside exploring real-world implementation issues to
address prior to undertaking the larger trial.
To conduct the study, the investigators will consecutively approach two populations: adult
advanced cancer patients (defined as any Stage IV solid tumor malignancy, or Stage III
pancreas or lung cancer) in the GI, GU, and Thoracic Cancer Clinics with a diagnosis made in
the preceding eight weeks. The investigators will primarily evaluate usability through
evaluating subject-reported perceived usefulness. .
The investigators will also measure change in patient self-efficacy and change knowledge of
palliative care scores alongside obtaining baseline data on palliative care referral rates.
To evaluate perceived usefulness, the investigators will use the Perceived Usefulness Scale
and Ease of Use subscales of the System Usability Scale, common tools used in health
technology evaluations30 and a single item "I feel prepared for the palliative care visit".
Lastly, the investigators will measure subsequent referrals to palliative care, comparing the
Ēlos cohort with a non-intervention cohort. the investigators will compare three cohorts: 1).
Ēlos intervention cohort; 2). An age-, disease-, and stage-matched cohort of usual care
patients during the same time period as the intervention; and 3). A similarly-matched cohort
who received usual oncology care six months prior to the study. The latter control cohort
evaluates palliative care referral practices prior to any intervention taking place to reduce
contamination. The investigators will use these preliminary data on referral rates to
determine the effect sizes needed to calculate the sample sizes for an Alliance CCDR protocol
for a NCORP trial.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
| Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
| Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
| Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
| Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
| Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 |