Electronic Patient Reporting of Symptoms and Unmet Needs to Connect Patients With Advanced Cancer to Palliative Care Services

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-10-31

Brief Summary

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This study is testing whether electronic surveys can help patients with advanced cancer report their symptoms and care needs so their doctors can connect them to palliative/supportive care services sooner. The goal is to see if this approach can make it easier for patients to get support for symptoms, quality of life, and other needs during cancer treatment.

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Detailed Description

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Patients with advanced cancer often experience a range of symptoms and needs while undergoing treatment. Palliative care services aim to address these needs and improve quality of life by preventing and relieving physical, emotional, social, and spiritual suffering.

Palliative care is a specialized type of medical care provided by a team of doctors, nurses, and other professionals who work together with the oncology team. The focus of palliative care is to improve comfort and well-being by treating symptoms such as pain, fatigue, or shortness of breath, and by supporting patients and their families as they cope with the challenges of serious illness. Research has shown that when palliative care is introduced early, patients may experience better symptom control, improved mood and quality of life, and family members may feel less distressed.

Despite these benefits, many patients do not receive timely palliative care because it can be difficult to identify those with unmet needs, and there are not enough specialists available to meet demand.

This study will test a structured approach that uses electronic patient-reported outcomes (ePROs) to support timely referral to palliative care services. Participants in the intervention arm will receive palliative care education from a trained study coordinator, complete weekly ePRO symptom monitoring surveys, and complete monthly ePRO surveys focused on broader palliative care needs. Severe or persistent symptoms reported through these surveys will trigger an alert to the oncology team with a recommendation for palliative care referral. In addition, participants will be offered navigation support to connect with palliative care services.

Participants in the control arm will complete weekly ePRO symptom monitoring surveys, with referral to palliative care occurring according to usual clinical practice.

Conditions

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Palliative Care Referral Advanced Cancer Palliative Care, Health Services Metastatic Cancer (Different Solid Tumour Types)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm pilot randomized controlled trial (n=90; 2:1 allocation) comparing an ePRO-directed referral intervention to palliative/supportive care vs. weekly ePRO symptom monitoring.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ePRO-Directed Referral Intervention

Participants receive: (1) palliative care education from a trained study coordinator; (2) weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys; (3) monthly ePRO palliative care surveys; and (4) navigation to palliative care services when a referral is placed. Severe or persistent patient-reported symptoms or unmet care needs identified through ePROs will trigger an alert to the oncology team with a recommendation for palliative care referral.

Group Type EXPERIMENTAL

ePRO-Directed Referral and Navigation to Palliative/Supportive Care

Intervention Type BEHAVIORAL

This intervention combines routine electronic patient-reported outcome (ePRO) symptom monitoring with additional components designed to connect patients more directly to palliative/supportive care. In addition to weekly ePRO symptom surveys, participants complete a monthly palliative care-focused ePRO survey, receive structured palliative care education from a trained study coordinator, and are offered navigation support to facilitate access to palliative/supportive care services. Severe or persistent symptoms or unmet needs reported on ePROs generate an alert to the oncology team along with a recommendation for palliative care referral. This multicomponent approach is intended to address gaps in timely referral and access to palliative/supportive care that are not addressed through symptom monitoring alone.

ePRO Symptom Monitoring with Usual Palliative Care Referral

Participants complete weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys as standard care in oncology practice. ePRO results are shared with their oncology team for routine care. Referral to palliative care occurs according to usual clinical practice.

Group Type OTHER

ePRO Symptom Monitoring with Usual Palliative Care Referral

Intervention Type OTHER

Participants complete weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys. Survey results are shared with the oncology team to support routine care. Referral to palliative/supportive care is made according to usual clinical practice at the discretion of the oncology team. Unlike the intervention arm, participants do not receive structured palliative care education, a monthly palliative care-focused ePRO survey, navigation support, or referral alerts generated from persistent or severe symptoms and unmet care needs.

Interventions

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ePRO-Directed Referral and Navigation to Palliative/Supportive Care

This intervention combines routine electronic patient-reported outcome (ePRO) symptom monitoring with additional components designed to connect patients more directly to palliative/supportive care. In addition to weekly ePRO symptom surveys, participants complete a monthly palliative care-focused ePRO survey, receive structured palliative care education from a trained study coordinator, and are offered navigation support to facilitate access to palliative/supportive care services. Severe or persistent symptoms or unmet needs reported on ePROs generate an alert to the oncology team along with a recommendation for palliative care referral. This multicomponent approach is intended to address gaps in timely referral and access to palliative/supportive care that are not addressed through symptom monitoring alone.

Intervention Type BEHAVIORAL

ePRO Symptom Monitoring with Usual Palliative Care Referral

Participants complete weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys. Survey results are shared with the oncology team to support routine care. Referral to palliative/supportive care is made according to usual clinical practice at the discretion of the oncology team. Unlike the intervention arm, participants do not receive structured palliative care education, a monthly palliative care-focused ePRO survey, navigation support, or referral alerts generated from persistent or severe symptoms and unmet care needs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years.
2. Diagnosis of unresectable or metastatic, incurable thoracic, gastrointestinal, or breast solid tumor.
3. Receiving active cancer-directed therapy longitudinally in the outpatient oncology clinic and expected to continue treatment.

Exclusion Criteria

1. Members of vulnerable populations, including infants, minors, individuals unable to provide informed consent, and those who are incarcerated or imprisoned at the time of enrollment.
2. Already established with palliative care, defined as having a scheduled future palliative care appointment, a pending referral, or a visit with palliative care within the past 90 days.
3. Unable to provide informed consent in English.
4. Cognitive impairment that, in the judgment of the treating clinician, would preclude study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No