Palliative Care ReferralPRO-CONNECTNCT07195513
Electronic Patient Reporting of Symptoms and Unmet Needs to Connect Patients With Advanced Cancer to Palliative Care Services
A study testing ePRO-Directed Referral and Navigation to Palliative/Supportive Care and ePRO Symptom Monitoring with Usual Palliative Care Referral in people with Palliative Care Referral and Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care Referral, Advanced Cancer, Palliative Care, Health Services
- What is being tested?
- ePRO-Directed Referral and Navigation to Palliative/Supportive Care and ePRO Symptom Monitoring with Usual Palliative Care Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Delaney K. Reese, MS, 603-650-3784, Delaney.K.Reese@Hitchcock.org
Loretta H Pearson, MPhil, CCRC, 603-653-3561, Loretta.H.Pearson@Hitchcock.org
About this study
Official title: "PRO-CONNECT" Patient-Reported Outcomes to Coordinate Supportive Care for Unmet Needs During Cancer Treatment
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.
Read the 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.
- Conditions
- Palliative Care Referral, Advanced Cancer, Palliative Care, Health Services, Metastatic Cancer (Different Solid Tumour Types)
- Being tested
- ePRO-Directed Referral and Navigation to Palliative/Supportive Care, ePRO Symptom Monitoring with Usual Palliative Care Referral
- Keywords
- ePROs, Patient Reported Outcomes, Palliative Care, Supportive Care, Advanced Cancer, Metastatic Cancer
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePRO-Directed Referral and Navigation to Palliative/Supportive CareBehavioural
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 ReferralOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ePRO-Directed Referral and Navigation to Palliative/Supportive Care |
| 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. Receives: Other: ePRO Symptom Monitoring with Usual Palliative Care Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 and 24 weeks
Secondary outcomes (10)
Referral Rates to Palliative/Supportive Care
Proportion of patients referred to palliative/supportive care during the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment though end of study at week 24
Adoption
Proportion of PRO reports and referral alerts viewed by providers.
Measured: 12 and 24 weeks
Appropriateness
Perceived relevance, usefulness, practicability of the intervention among patients and providers, using an Exit Survey and Study End interview.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start25 Feb 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative Care ReferralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society (ACS)
- Responsible party
- Principal investigator, Tara.L.Kaufmann, Dartmouth-Hitchcock Medical Center
- Investigators
- Tara L. Kaufmann, MD, MSCE, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195513
- Sponsor's protocol ID
- CSDG-23-1019130-01 CTPS
- Acronym
- PRO-CONNECT
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 2025 Mar 10.
PubMed 40059654
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "PRO-CONNECT" Patient-Reported Outcomes to Coordinate Supportive Care for Unmet Needs During Cancer Treatment
- ClinicalTrials.gov ID
- NCT07195513
- Acronym / sponsor ID
- PRO-CONNECT / CSDG-23-1019130-01 CTPS
- Conditions
- Palliative Care Referral, Advanced Cancer, Palliative Care, Health Services, Metastatic Cancer (Different Solid Tumour Types)
- Keywords
- ePROs, Patient Reported Outcomes, Palliative Care, Supportive Care, Advanced Cancer, Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society (ACS)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ePRO-Directed Referral Intervention | Experimental | Behavioral: ePRO-Directed Referral and Navigation to Palliative/Supportive CareParticipants 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 | Other | Other: ePRO Symptom Monitoring with Usual Palliative Care ReferralParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePRO-Directed Referral and Navigation to Palliative/Supportive CareThis 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. | Behavioural | ePRO-Directed Referral Intervention |
| ePRO Symptom Monitoring with Usual Palliative Care ReferralParticipants 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. | Other | ePRO Symptom Monitoring with Usual Palliative Care Referral |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 40059654Kaufmann 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tara L. Kaufmann, MD, MSCE principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePRO-Directed Referral and Navigation to Palliative/Supportive Care and ePRO Symptom Monitoring with Usual Palliative Care Referral in people with Palliative Care Referral and Advanced Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delaney K Reese, MS (603-650-3784, Delaney.K.Reese@Hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention & Trial Methods (time frame: 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07195513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.