Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •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
- •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
排除标准
- •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:
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 (Behavioral)
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 (Behavioral)
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)