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.
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.
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.
Parallel
ePRO-Directed Referral and Navigation to Palliative/Supportive Care
BehavioralThis 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
Other interventionParticipants 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.
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.
Referral Rates to Palliative/Supportive Care
Proportion of patients referred to palliative/supportive care during the study period.
Patient Engagement with Palliative Care
Proportion of patients who attend the first palliative care visit among population referred to Palliative Care.
Sustainability
Recommendation for continued use of the intervention beyond the study period among patients and providers as determined by an Exit Survey and Study End Interview.
Fidelity
Proportion of ePROs delivered to patients, referral alerts sent for ePRO threshold triggers, and patients contacted for palliative care referrals.
Patient-Centered Communication
Patient-Centered Communication as measured by the Patient-Centered Communication-Cancer-6 (PCC-Ca-6) survey. The overall score is a computed average across all completed responses, where the individual responses are scored from 1-5 with higher scores indicating better communication.
Coping Self-Efficacy
Coping self-efficacy as measured by the Cancer Behavior Inventory - Brief Version (CBI-B) survey instrument Individual responses are scored from 1-9, where the total raw score is the sum of all the scored responses, with higher scores indicating better coping abilities.
Aggressive End-Of-Life Care
Among participants who die during follow-up, proportion meeting any of the following indicators of aggressive end-of-life care: (a) hospice enrollment ≤3 days before death; (b) ≥1 hospitalization within 30 days of death; (c) receipt of chemotherapy within 14 days of death. Components will also be reported separately.
Place of Death Concordance with Preference
Among participants who die during follow-up, the proportion whose actual place of death matches their documented preferred place of death. Patient preferences will be collected from the electronic health record (EHR).
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Dartmouth-Hitchcock Medical Center
Lead sponsor
American Cancer Society (ACS)
Collaborator
