Advanced Cancer, Metastatic Cancer (Different Solid Tumour Types), Palliative Care, Health Services, Palliative Care Referral
Conditions
Keywords
ePROs, Patient Reported Outcomes, Palliative Care, Supportive Care, Advanced Cancer, Metastatic Cancer
Brief 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. 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.
Interventions
BEHAVIORALePRO-Directed Referral and Navigation to Palliative/Supportive Care
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.
OTHERePRO Symptom Monitoring with Usual Palliative Care Referral
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.
Sponsors
Dartmouth-Hitchcock Medical Center
American Cancer Society (ACS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Diagnosis of unresectable or metastatic, incurable thoracic, gastrointestinal, or breast solid tumor. 3. Receiving active cancer-directed therapy longitudinally in the outpatient oncology clinic and expected to continue treatment.
Exclusion criteria
1. 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. 2. 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. 3. Unable to provide informed consent in English. 4. Cognitive impairment that, in the judgment of the treating clinician, would preclude study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention & Trial Methods | 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
| Measure | Time frame | Description |
|---|---|---|
| Referral Rates to Palliative/Supportive Care | 12 and 24 weeks | Proportion of patients referred to palliative/supportive care during the study period. |
| Patient Engagement with Palliative Care | 12 and 24 weeks | Proportion of patients who attend the first palliative care visit among population referred to Palliative Care. |
| Sustainability | 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. |
| Fidelity | 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. |
| Adoption | 12 and 24 weeks | Proportion of PRO reports and referral alerts viewed by providers. |
| Appropriateness | 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. |
| Acceptability | 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. |
| Health-related Quality of Life | 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. |
| Patient-Reported Pain | 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. |
| Patient-reported Mood | 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. |
Countries
United States
Contacts
CONTACTDelaney K Reese, MS
CONTACTLoretta H Pearson, MPhil, CCRC
PRINCIPAL_INVESTIGATORTara L. Kaufmann, MD, MSCE
Dartmouth-Hitchcock Medical Center
Outcome results
None listed