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临床试验/NCT06634381
NCT06634381
招募中
不适用

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

Wake Forest University Health Sciences5 个研究点 分布在 1 个国家目标入组 80 人2025年3月12日
适应症CancerFatigue
干预措施CRF Visual Aid

概览

阶段
不适用
干预措施
CRF Visual Aid
疾病 / 适应症
Cancer
发起方
Wake Forest University Health Sciences
入组人数
80
试验地点
5
主要终点
Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors
状态
招募中
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2025年3月12日
结束日期
2028年6月1日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Ability to comply with study procedures for the duration of the study
  • 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
  • White or Caucasian, Black or African American, or Hispanic or Latino/a
  • 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 fatigue score of ≥ 4 on the Numerical Rating Scale
  • Clinicians:
  • \- Currently see oncology patients (any cancer type) for survivorship care at LCH and/or the Charlotte or Winston-Salem campuses of AHWFBCCC

排除标准

  • Continuing maintenance therapy or other cancer-related treatment (i.e. immunotherapy or hormonal therapy)
  • History of or current severe or untreated 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:

研究组 & 干预措施

Survivors

Cancer survivors with any type of cancer and a history of at least 1 visit for the purpose of monitoring long term care post curative treatment at LCH and/or the Charlotte or Winston-Salem campuses of AHWFBCCC who have completed curative treatment for more than 6 months.

干预措施: CRF Visual Aid

Clinicians

Any providers working with post-treatment oncology survivors at LCH and the Charlotte or Winston Salem campuses of AHWFBCCC.

干预措施: CRF Visual Aid

结局指标

主要结局

Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors

时间窗: Seven months from baseline

A domain is a topic that people talk about that has sub-items characterizing the distinct features and levels of importance within the domain. Using qualitative analysis, evaluation of how survivors think and talk about CRF to generate domain classifications of language. Domain is a categorical variable.

次要结局

  • Qualitative themes derived from open-ended interviews of clinicians(Five months from screening)
  • Domains reflecting CRF experiences in cancer survivors(Seven months from baseline)
  • Appropriateness of the visual aid to alleviate survivor-clinician communication barriers(Eleven months from baseline)

研究点 (5)

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