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| Name | Class |
|---|---|
| American Cancer Society (ACS) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePRO-Directed Referral Intervention | Experimental | 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Referral Rates to Palliative/Supportive Care | Proportion of patients referred to palliative/supportive care during the study period. | 12 and 24 weeks |
| Patient Engagement with Palliative Care | Proportion of patients who attend the first palliative care visit among population referred to Palliative Care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 and 24 weeks |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delaney K Reese, MS | Contact | 603-650-3784 | Delaney.K.Reese@Hitchcock.org | |
| Loretta H Pearson, MPhil, CCRC | Contact | 603-653-3561 | Loretta.H.Pearson@Hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Tara L. Kaufmann, MD, MSCE | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40059654 | Background | 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. |
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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.
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Two-arm pilot randomized controlled trial (n=90; 2:1 allocation) comparing an ePRO-directed referral intervention to palliative/supportive care vs. weekly ePRO symptom monitoring.
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| 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. |
|
| 12 and 24 weeks |
| 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. | 24 weeks [Exit Survey] / 36 weeks [Study End interviews] |
| Fidelity | Proportion of ePROs delivered to patients, referral alerts sent for ePRO threshold triggers, and patients contacted for palliative care referrals. | From enrollment though end of study at week 24 |
| Adoption | Proportion of PRO reports and referral alerts viewed by providers. | 12 and 24 weeks |
| Appropriateness | Perceived relevance, usefulness, practicability of the intervention among patients and providers, using an Exit Survey and Study End interview. | 24 weeks [Exit Survey] / 36 weeks [Study End interviews] |
| Acceptability | Satisfaction with intervention (content, complexity, comfort, delivery) among patients and providers, using an Exit Survey and optional Study End Interviews. | 24 weeks [Exit Survey] / 36 weeks [Study End interviews] |
| Health-related Quality of Life | 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. | 12 and 24 weeks |
| Patient-Reported Pain | 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. | 12 and 24 weeks |
| Patient-reported Mood | 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. | 12 and 24 weeks |
| 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. |
| 12 and 24 weeks |
| 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. | From enrollment through death (assessed up to 24 weeks) |
| 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). | From enrollment through death (assessed up to 24 weeks) |
| Advanced Care Planning | 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. | Enrollment through 24 weeks |
| Healthcare Utilization: Emergency Room Visits and Hospitalizations | 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. | 12 and 24 weeks |
| Outpatient Palliative Care Utilization | 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. | 12 and 24 weeks |
| Psychosocial Support Service Utilization | Proportion of patients who receive oncology social worker contact or psycho-oncology care. | 12 and 24 weeks |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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