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Идёт набор NCT00505245

New Assessment System in Measuring Symptom Distress in Cancer Patients

— Наблюдательное Caregiver Health Care Provider Malignant Neoplasm Physician

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: Interview, Quality-of-Life Assessment, Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Caregiver, Health Care Provider, Malignant Neoplasm, Physician. 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

Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

Обзор

This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.

Подробное описание

PRIMARY OBJECTIVES:

I. To examine how the MD Anderson Inventory (MD Anderson Symptom Inventory \[MDASI\]) or other MD Anderson-developed patient reported outcome (PRO) instrument performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.

II. To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life.

III. To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).

IV. To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.

V. To explore the utility of an interactive voice response (IVR) system in enhancing the clinical care of outpatients.

VI. To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols.

VII. To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data.

OUTLINE:

Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

Вмешательства

  • Другое Interview
    Complete interview
  • Другое Quality-of-Life Assessment
    Complete quality of life assessment
  • Другое Questionnaire Administration
    Complete questionnaires

Первичные конечные точки

  • MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed patient reported outcome (PRO) instrument validity [Срок оценки: Up to 21 years]
  • MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument reliability. [Срок оценки: Up to 21 years]
  • MD Anderson Symptom Inventory [Срок оценки: Baseline up to 21 years]
  • Eastern Cooperative Oncology Group Functional Status scale [Срок оценки: Baseline up to 21 years]
  • EuroQOL 5 Dimensions questionnaire [Срок оценки: Baseline up to 21 years]
  • The change in the symptom severity and interference with the function [Срок оценки: Baseline up to 21 years]
  • MD Anderson Symptom Inventory (MDASI) tool or other MD Anderson-developed PRO instrument sensitivity [Срок оценки: Up to 21 years]
  • The quality of life questionnaire will be assessed. [Срок оценки: Up to 21 years]

Критерии участия

Критерии включения

  • NORMAL SAMPLES: Community dwelling adults 18 years of age or older
  • PATIENT SAMPLES: Inpatients and outpatients 18 years of age or older, being followed at UT MD Anderson
  • EXPERT PANEL PROFESSIONAL PARTICIPANTS: Physician or other healthcare provider with at least 5 years of experience caring for patients with the disease and/or treatment of interest, at least one publication in the last 5 years dealing with the disease and/or treatment of interest (physician only), ability to speak and read English, consent to participate
  • EXPERT PANEL FAMILY CAREGIVERS PARTICIPANTS: Identification as a family caregiver by patient enrolled as expert panel participant with the disease and/or treatment of interest, 18 years of age or older, ability to speak and read English, consent to participate
  • EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on Expert Panel, willingness to receive packet for expert panel participation

Критерии исключения

  • EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT00505245 · BS99-094 · NCI-2018-02461 · BS99-094 · P30CA016672 · R01CA205146

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗