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Идёт набор NCT06634381

Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors

— Наблюдательное Cancer Fatigue

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: CRF Visual Aid.
Кому может быть актуально
Состояния в реестре: Cancer, Fatigue. 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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Обзор

The purpose of this research study is to better understand how cancer-related fatigue affects patients and how it's discussed with providers. This information will be used to develop an educational resource (visual aid poster) that could help individuals and their providers talk about cancer-related fatigue and which may help individuals better manage this symptom.

Подробное описание

This is a mixed methods cross-sectional pilot study. The target population is adults ≥ 18 years of age who have been diagnosed with cancer, have completed anti-cancer treatment more than six months ago, have no current detectable evidence of cancer, and are experiencing cancer-related fatigue. Participation in this research will involve completion of a six-minute walk test, survey completion, two virtual video interviews, and potentially one additional virtual interview. The interviews will include two 45 minutes for survivors and one 30-minute interview for clinicians. An additional 30-minute interview will be conducted for each survivor and clinician group.

Вмешательства

  • Поведенческое CRF Visual Aid
    After all qualitative interviews and associated quantitative data analysis are complete, the visual aid will be created to illustrate, through a type of Venn Diagram, how the data are related.

Первичные конечные точки

  • Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors [Срок оценки: Seven months from baseline]
Вторичные конечные точки (3)
  • Qualitative themes derived from open-ended interviews of clinicians [Срок оценки: Five months from screening]
  • Domains reflecting CRF experiences in cancer survivors [Срок оценки: Seven months from baseline]
  • Appropriateness of the visual aid to alleviate survivor-clinician communication barriers [Срок оценки: Eleven months from baseline]

Критерии участия

Критерии включения

  • Ability to comply with study procedures for the duration of the study

Survivors:

  • Written informed consent and HIPAA authorization for release of personal information
  • Ability to read/write, understand and converse in English without the need for an interpreter
  • Men and women aged ≥ 18 years at the time of consent
  • History of at least one visit for the purpose of monitoring long term care post curative treatment at LCH and/or the Charlotte or Winston-Salem campuses of AHWFBCCC
  • Completed curative treatment > 6 months ago for any cancer type, with no detectable evidence of cancer
  • Self-reported tiredness, exhaustion, or weakness (i.e. fatigue) score of ≥ 4 on the Numerical Rating Scale
  • Adjuvant endocrine therapy to reduce the risk of cancer returning is acceptable (i.e. tamoxifen or aromatase inhibitors).

Clinicians:

\- Currently see oncology patients (any cancer type) for survivorship care at LCH and/or the Charlotte or Winston-Salem campuses of AHWFBCCC

Критерии исключения

Survivors:

  • Continuing maintenance therapy or other cancer-related treatment (i.e. immunotherapy)
  • History of or current untreated Major Depressive Disorders or untreated severe depression
  • Hemoglobin <11g/dL at last CBC SOC lab collection
  • History/diagnosis of dementia
  • Factors or conditions, for which participation may (1) not be in the best interest or (2) interfere with study assessment results (e.g. medical comorbidities, primary brain tumor/metastases)
  • No access to internet/Wi-Fi

Clinicians:

\- None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Levine Childrens Hospital Pediatric Cancer and Blood Disorders — Charlotte
  • Levine Cancer Institute — Charlotte
  • Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

NCT: NCT06634381 · IRB00119101 · ONC-CCS-2402

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗