Electronic Patient Reporting of Symptoms and Unmet Needs to Connect Patients With Advanced Cancer to Palliative Care Services (PRO-CONNECT)

Dartmouth Health

Status: Not yet enrolling

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

Treatments: Other: ePRO Symptom Monitoring with Usual Palliative Care Referral; Behavioral: ePRO-Directed Referral and Navigation to Palliative/Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07195513

CSDG-23-1019130-01 CTPS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

ePRO-Directed Referral Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: ePRO-Directed Referral and Navigation to Palliative/Supportive Care

ePRO Symptom Monitoring with Usual Palliative Care Referral

Other group

Description:

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.

Treatment:

Other: ePRO Symptom Monitoring with Usual Palliative Care Referral