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

Official title

"PRO-CONNECT" Patient-Reported Outcomes to Coordinate Supportive Care for Unmet Needs During Cancer Treatment

Overview

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.

Detailed 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 be offered weekly ePRO symptom monitoring surveys with instructions on how to contact their oncology team for symptom management. Referral to palliative care occurs according to usual clinical practice.

Interventions

• Behavioral 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 pers
• Other ePRO Symptom Monitoring with Usual Palliative Care Referral
  Participants will be offered weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys and instructions on contacting the oncology team for symptom management. Referral to palliative care occurs according to usual clinical practice. Current standard of care processes for managing symptoms at DCC vary across clinics and may or may not include ePRO monitoring based on the practice of the individual clinician and disease team. Unlike the intervention arm, participants do not rece

Primary outcome measures

• Feasibility of the Intervention & Trial Methods [Time frame: 12 and 24 weeks]

Secondary outcome measures (10)

• Referral Rates to Palliative/Supportive Care [Time frame: 12 and 24 weeks]
• Patient Engagement with Palliative Care [Time frame: 12 and 24 weeks]
• Sustainability [Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]]
• Fidelity [Time frame: From enrollment though end of study at week 24]
• Adoption [Time frame: 12 and 24 weeks]
• Appropriateness [Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]]
• Acceptability [Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]]
• Health-related Quality of Life [Time frame: 12 and 24 weeks]
• Patient-Reported Pain [Time frame: 12 and 24 weeks]
• Patient-reported Mood [Time frame: 12 and 24 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.
• 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.
• Unable to provide informed consent in English.
• Cognitive impairment that, in the judgment of the treating clinician, would preclude study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Dartmouth-Hitchcock Medical Center — Lebanon

Publications

• Kaufmann TL, Kearney M, Cortez D, Saxton JW, Goodfellow K, Smith C, Chang P, Sebastian K, Galaznik A, Scott J, Kvale EA, Kamal AH, Bennett AV, Stover AM, Henneghan AM, Pignone M, Rocque GB. Feasibility Study of Using Electronic Patient-Reported Outcomes to Screen Patients with Advanced Solid Cancers for Palliative Care Needs. J Palliat Med. 2025 May;28(5):580-591. doi: 10.1089/jpm.2024.0375. Epub PMID 40059654

Identifiers

NCT: NCT07195513 · CSDG-23-1019130-01 CTPS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗