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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
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.
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.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
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.
Time frame: 12 and 24 weeks
Referral Rates to Palliative/Supportive Care
Proportion of patients referred to palliative/supportive care during the study period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment though end of study at week 24
Adoption
Proportion of PRO reports and referral alerts viewed by providers.
Time frame: 12 and 24 weeks
Appropriateness
Perceived relevance, usefulness, practicability of the intervention among patients and providers, using an Exit Survey and Study End interview.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 and 24 weeks
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