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NCT Number: NCT07195513

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

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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Key information

Conditions

Palliative Care Referral Advanced Cancer Metastatic Cancer (Different Solid Tumour Types) Neoplasm Metastasis Neoplasms Neoplastic Processes Palliative Care, Health Services Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ePRO-Directed Referral and Navigation to Palliative/Supportive Care

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

Other

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.

Primary outcomes

  1. Feasibility of the Intervention & Trial Methods

    Time frame: 12 and 24 weeks

    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.

Secondary outcomes

  1. Referral Rates to Palliative/Supportive Care

    Time frame: 12 and 24 weeks

    Proportion of patients referred to palliative/supportive care during the study period.

  2. Patient Engagement with Palliative Care

    Time frame: 12 and 24 weeks

    Proportion of patients who attend the first palliative care visit among population referred to Palliative Care.

  3. Sustainability

    Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]

    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.

  4. Fidelity

    Time frame: From enrollment though end of study at week 24

    Proportion of ePROs delivered to patients, referral alerts sent for ePRO threshold triggers, and patients contacted for palliative care referrals.

  5. Adoption

    Time frame: 12 and 24 weeks

    Proportion of PRO reports and referral alerts viewed by providers.

  6. Appropriateness

    Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]

    Perceived relevance, usefulness, practicability of the intervention among patients and providers, using an Exit Survey and Study End interview.

  7. Acceptability

    Time frame: 24 weeks [Exit Survey] / 36 weeks [Study End interviews]

    Satisfaction with intervention (content, complexity, comfort, delivery) among patients and providers, using an Exit Survey and optional Study End Interviews.

  8. Health-related Quality of Life

    Time frame: 12 and 24 weeks

    Quality of life as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Range 0-108 with higher scores indicating better quality of life.

  9. Patient-Reported Pain

    Time frame: 12 and 24 weeks

    Patient-reported pain as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey instrument.

    Each question is scored from 1 to 5, where the overall raw survey score ranges from 3-15 with higher scores indicating worse pain.

  10. Patient-reported Mood

    Time frame: 12 and 24 weeks

    Patient-reported mood as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression survey instruments.

    Each question is scored from 1 to 5 with higher scores indicating more emotional distress (anxiety or depression). For both instruments, the total raw score ranges from 8-40.

Other outcomes

  1. Patient-Centered Communication

    Time frame: 12 and 24 weeks

    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.

  2. Coping Self-Efficacy

    Time frame: 12 and 24 weeks

    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.

  3. Aggressive End-Of-Life Care

    Time frame: From enrollment through death (assessed up to 24 weeks)

    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.

  4. Place of Death Concordance with Preference

    Time frame: From enrollment through death (assessed up to 24 weeks)

    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).

  5. Advanced Care Planning

    Time frame: Enrollment through 24 weeks

    Proportion of participants with documentation in the electronic health record (EHR) of end-of-life care discussions, such as goals-of-care conversations, preferences for life-sustaining treatment, or hospice discussions, during the study period.

  6. Healthcare Utilization: Emergency Room Visits and Hospitalizations

    Time frame: 12 and 24 weeks

    Average number of emergency room visits and hospitalizations per participant. Data will be collected from the electronic health record (EHR) and from patient surveys. Aggregation method: mean number of visits per participant, with standard deviation (SD), and proportion of participants with ≥1 event at each time point.

  7. Outpatient Palliative Care Utilization

    Time frame: 12 and 24 weeks

    Average number of palliative care visits per participant. Aggregation method: mean number of visits per participant, with standard deviation (SD), and proportion of participants with ≥1 visit at each time point.

  8. Psychosocial Support Service Utilization

    Time frame: 12 and 24 weeks

    Proportion of patients who receive oncology social worker contact or psycho-oncology care.

Study contacts

Contact information is provided by the study sponsor or research team.

Delaney K Reese, MS

CONTACT

[email protected]

603-650-3784

Loretta H Pearson, MPhil, CCRC

CONTACT

[email protected]

603-653-3561

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • American Cancer Society (ACS)

Registry information

Official study title

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

Acronym: PRO-CONNECT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 26, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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