"PRO-CONNECT" Patient-Reported Outcomes to Coordinate Supportive Care for Unmet Needs During Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility of the Intervention & Trial Methods
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ePRO 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.
干预措施: ePRO Symptom Monitoring with Usual Palliative Care Referral (Other)
ePRO-Directed Referral 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.
干预措施: ePRO-Directed Referral and Navigation to Palliative/Supportive Care (Behavioral)
结局指标
主要结局
Feasibility of the Intervention & Trial Methods
时间窗: 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.
次要结局
- Patient Engagement with Palliative Care(12 and 24 weeks)
- Referral Rates to Palliative/Supportive Care(12 and 24 weeks)
- Sustainability(24 weeks [Exit Survey] / 36 weeks [Study End interviews])
- Fidelity(From enrollment though end of study at week 24)
- Adoption(12 and 24 weeks)
- Appropriateness(24 weeks [Exit Survey] / 36 weeks [Study End interviews])
- Acceptability(24 weeks [Exit Survey] / 36 weeks [Study End interviews])
- Health-related Quality of Life(12 and 24 weeks)
- Patient-Reported Pain(12 and 24 weeks)
- Patient-reported Mood(12 and 24 weeks)
研究者
Tara.L.Kaufmann
Principal Investigator
Dartmouth-Hitchcock Medical Center