Electronic Symptom Reporting for Cancer

(PRO-CONNECT Trial)

Overseen By Loretta H Pearson, MPhil, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Vulnerable populations, Palliative care, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electronic surveys can help patients with advanced cancer report symptoms and care needs more easily. The goal is to determine if this method, known as ePRO-Directed Referral and Navigation to Palliative/Supportive Care, can connect patients to supportive care services more quickly, thereby improving their quality of life during treatment. The trial includes patients with advanced thoracic, gastrointestinal, or breast cancer who are receiving ongoing treatment but are not currently using palliative care services. Participants complete surveys about their symptoms, and the results guide their care team's decisions. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could enhance care for others in the future.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on symptom reporting rather than medication changes.

What prior data suggests that this electronic symptom reporting method is safe for cancer patients?

Studies have shown that electronic patient-reported outcomes (ePROs) are safe and helpful for managing symptoms in cancer patients. Research indicates that ePROs simplify symptom sharing, leading to improved care and support. Patients using ePROs have reported no major safety concerns. This method is well-accepted and enables doctors to quickly understand patient needs, connecting them to necessary services like palliative care. Overall, ePROs offer a reliable way to enhance patient care without added risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve palliative care for cancer patients through electronic symptom reporting (ePRO). Unlike traditional methods, where palliative care referrals depend heavily on clinical judgment and patient-initiated requests, this approach uses weekly ePRO surveys to actively monitor symptoms. The ePRO-Directed Referral Intervention goes a step further by providing palliative care education and direct navigation to services, triggering alerts for the oncology team when severe symptoms or unmet needs are detected. This proactive and tech-driven approach has the potential to ensure timely and personalized care, enhancing the overall quality of life for patients.

What evidence suggests that this trial's electronic symptom reporting methods could be effective for cancer patients?

This trial compares two approaches to electronic symptom reporting for cancer patients. Research has shown that electronic surveys for symptom reporting can improve cancer symptom management. In one arm of the trial, participants will complete weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys as standard care, with results shared with their oncology team for routine care. In the other arm, participants will receive an ePRO-Directed Referral Intervention, which includes palliative care education, weekly ePRO symptom monitoring, and navigation to palliative care services when needed. These surveys allow patients to easily report issues like anxiety, tiredness, and nausea, enabling doctors to quickly connect patients with appropriate support services. Regular use of these electronic surveys is considered a key method to enhance care by alerting doctors to serious or ongoing symptoms. Patients generally prefer this method because it simplifies and improves communication about their care needs. ^{1 6 7 8 9}

Who Is on the Research Team?

Tara L. Kaufmann, MD, MSCE

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced, incurable thoracic, gastrointestinal, or breast cancer who are undergoing ongoing outpatient treatment and expected to continue. It's not for those already in palliative care, unable to consent, incarcerated, or with cognitive impairments.

Inclusion Criteria

I am 18 years old or older.

My cancer cannot be removed by surgery and has spread.

I am currently undergoing cancer treatment and will continue it.

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

I am already receiving or scheduled to receive palliative care.

I cannot give informed consent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive palliative care education, complete weekly ePRO symptom monitoring surveys, and monthly ePRO surveys focused on broader palliative care needs. Alerts are triggered for severe or persistent symptoms.

24 weeks

Weekly electronic surveys, monthly electronic surveys

Follow-up

Participants are monitored for engagement with palliative care and other outcomes such as quality of life and healthcare utilization.

12 weeks

Study End Interviews

Exit surveys and study end interviews to assess sustainability, appropriateness, and acceptability of the intervention.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ePRO-Directed Referral and Navigation to Palliative/Supportive Care
• ePRO Symptom Monitoring

Trial Overview The study tests if electronic patient-reported outcomes (ePRO) can better connect patients with advanced cancer to palliative care by reporting symptoms and needs. One group uses ePRO-directed referrals while the other follows usual care referral processes.

How Is the Trial Designed?

Group I: ePRO-Directed Referral Intervention Experimental Treatment 1 Intervention

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.

Group II: ePRO Symptom Monitoring with Usual Palliative Care Referral Experimental Treatment 1 Intervention

Participants complete weekly electronic patient-reported outcome (ePRO) symptom monitoring surveys as standard care in oncology practice. ePRO results are shared with their oncology team for routine care. Referral to palliative care occurs according to usual clinical practice.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

American Cancer Society (ACS)

Collaborator

Trials

1

Recruited

250+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07195513

Electronic Patient Reporting of Symptoms and Unmet ... This study is testing whether electronic surveys can help patients with advanced cancer report their symptoms and care needs so their ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00270

Using Electronic Patient-Reported Outcome Monitoring to ... Routine ePRO symptom monitoring can be viewed as a primary palliative care intervention that improves symptom management by the oncology team.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9500127/

Electronic patient-reported outcomes (e-PROMs) in palliative ... Appreciated by patients, e-PROMs in palliative cancer care collect data related to symptoms such as anxiety, drowsiness, fatigue, nausea ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jpm.2024.0375

Feasibility Study of Using Electronic Patient-Reported ... We developed a 13-item ePRO palliative care survey to assess multidimensional palliative care needs and conducted a pilot study (n = 25) of a palliative ...

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.20.00015

Electronic Patient-Reported Outcome–Based Interventions ... We performed a systematic and mapping review of the scientific literature on the current ePRO-based approaches used for palliative cancer care.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949820124000663

Implementing digital patient-reported outcomes in routine ... We wanted to review specific published experiences identified as barriers to and facilitators of the implementation of digital PROs in routine cancer care.

7. researchgate.net researchgate.net/publication/343143043_Electronic_Patient-Reported_Outcome-Based_Interventions_for_Palliative_Cancer_Care_A_Systematic_and_Mapping_Review

Electronic Patient-Reported Outcome–Based Interventions ... We performed a systematic and mapping review of the scientific literature on the current ePRO-based approaches used for palliative cancer care.

8. cms.gov cms.gov/priorities/innovation/media/document/eom-elec-pat-rpt-outcomes

EOM Electronic Patient-Reported Outcomes Guide EOM participants should consider directing beneficiaries with newly identified symptoms to supportive care programs such as palliative care, ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38917403/

Using Electronic Patient-Reported Outcome Monitoring to ... Dr Kaufmann and Dr Rocque envision how #ePRO symptom monitoring can link patients to supportive care services. #pallonc #supponc #patientreportedoutcomes ...