Набор скоро начнётся NCT07723495

Symptom Management to Improve Completion of Patient-reported Outcome Measures

Без фазы С лечением Malignant Solid Neoplasm Malignant Head and Neck Neoplasm Malignant Lung Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Monitoring of PROMIS symptoms and physical function, Monitoring of additional symptoms and symptom self-management.
Кому может быть актуально: Состояния в реестре: Malignant Solid Neoplasm, Malignant Head and Neck Neoplasm, Malignant Lung Neoplasm. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)

Обзор

In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only \~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.

Подробное описание

PRIMARY OBJECTIVE:

1\. To test the effectiveness of the intervention's enhanced patient reported outcome (PRO) monitoring strategy (offer of nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms and evidence-based self-management strategies for elevated symptoms) versus the active control (receipt of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures) on PRO monitoring reach and penetration \[PRO assessment completion\] over 6 months.

SECONDARY OBJECTIVES:

1. Test the extent to which any differences in PRO monitoring reach and penetration between intervention and control arms at month 6 are explained by patient's symptom management self-efficacy and expectancy at month 3 (potential mechanisms). 2. Test the extent to which any differences in PRO monitoring reach and penetration at month 6 between intervention and control arms differ according to patient, disease and treatment characteristics (e.g., age, site and stage of cancer, concurrent radiation therapy).

Вмешательства

Поведенческое Monitoring of PROMIS symptoms and physical function
Patients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room. The scores are recorded in their health record and available for review by health care providers.
Поведенческое Monitoring of additional symptoms and symptom self-management
Assessments of additional symptoms from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be offered via Computerized Intervention Authoring System (CIAS). For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit.

Первичные конечные точки

Reach of patient reported outcome (PRO) assessment completion [Срок оценки: 6 months]
Penetration of patient reported outcome (PRO) assessment completion [Срок оценки: 6 months]

Критерии участия

Критерии включения

1\) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.
2\) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.
3\) Able to read and understand English.
4\) Cognitively oriented to person, place and time (determined by recruiter).