Technology-Enhanced Palliative Care for Advanced Cancer Patients

Technology-Enhanced Palliative Care for Cancer Patients

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.

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.

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