Technology-Enhanced Palliative Care for Advanced Cancer Patients
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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
119 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Ishwaria M. Subbiah
Data sourced from clinicaltrials.gov
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