Electronic Patient Reporting of Symptoms and Unmet Needs to Connect Patients With Advanced Cancer to Palliative Care Services
PRO-CONNECT
"PRO-CONNECT" Patient-Reported Outcomes to Coordinate Supportive Care for Unmet Needs During Cancer Treatment
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2025
CompletedFirst Posted
Study publicly available on registry
September 26, 2025
CompletedStudy Start
First participant enrolled
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 10, 2026
March 1, 2026
2.1 years
September 19, 2025
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of the Intervention & Trial Methods
Feasibility will be assessed as a composite of three prespecified components, each summarized as a proportion with 95% confidence intervals: Enrollment: Proportion of eligible patients who provide informed consent and are randomized. Retention: Proportion of randomized patients who complete the FACT-G at 12 weeks \[primary feasibility outcome\] and 24 weeks. Intervention Compliance: Weekly ePRO symptom surveys: Longitudinal compliance quantified as the proportion of participants who self-report at least once in each week of enrollment, averaged over the observation period. Monthly palliative-care ePRO surveys (intervention arm): Longitudinal compliance quantified as the proportion of participants who self-report at least once in each month of enrollment, averaged over the observation period.
12 and 24 weeks
Secondary Outcomes (10)
Referral Rates to Palliative/Supportive Care
12 and 24 weeks
Patient Engagement with Palliative Care
12 and 24 weeks
Sustainability
24 weeks [Exit Survey] / 36 weeks [Study End interviews]
Fidelity
From enrollment though end of study at week 24
Adoption
12 and 24 weeks
- +5 more secondary outcomes
Other Outcomes (8)
Patient-Centered Communication
12 and 24 weeks
Coping Self-Efficacy
12 and 24 weeks
Aggressive End-Of-Life Care
From enrollment through death (assessed up to 24 weeks)
- +5 more other outcomes
Study Arms (2)
ePRO-Directed Referral Intervention
EXPERIMENTALParticipants 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.
ePRO Symptom Monitoring with Usual Palliative Care Referral
OTHERParticipants 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.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Cancer Society (ACS)collaborator
- Dartmouth-Hitchcock Medical Centerlead
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Related Publications (1)
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 2025 Mar 10.
PMID: 40059654BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tara L. Kaufmann, MD, MSCE
Dartmouth-Hitchcock Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 19, 2025
First Posted
September 26, 2025
Study Start
February 25, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because this is a small, single-site pilot study of patients with advanced cancer, and the risk of re-identification is high. Preparing de-identified datasets for external use is not feasible for this study. Aggregate study results, including feasibility and implementation outcomes, will be shared publicly through ClinicalTrials.gov and peer-reviewed publications. Study protocol and summary materials will be available upon request.