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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess the effect size of each palliative care intervention technology-enhanced palliative care, standard palliative care [SPC]) on the symptom burden of patients prior to or while on a phase I trial. SECONDARY OBJECTIVES: I To estimate the effect size of each palliative care intervention (TEC, SPC) on symptom burden over a 12-week period of a phase I trial. II. To estimate the effect size of each palliative care intervention (TEC, SPC) on clinical outcomes at 6 months post-enrollment. III. To qualitatively assess patients' and caregivers' perceptions of receiving each TEC-based palliative care (PC) Intervention. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: 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. ARM II: 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 330-45 minutes during week 8. ARM III: 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. In all 3 arms, follow-up communication will occur as deemed necessary by the PC team. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm

NCT number NCT04989556
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date August 20, 2020
Completion date May 7, 2024

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