Technology-Enhanced Palliative Care for Advanced Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2026-05-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

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Comfort Care PA-Palliative Therapy palliation Palliative Palliative Care Palliative Treatment Symptom Management Symptoms Management Comfort Care PA-Palliative Therapy palliation Palliative Palliative Care Palliative Treatment Symptom Management Symptoms Management Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No