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Patient Descriptors of Cancer-Related Fatigue: a Mixed Methods Pilot Study of Cancer Survivors

Not yet recruiting
Conditions
Cancer
Fatigue
Interventions
Behavioral: CRF Visual Aid
Registration Number
NCT06634381
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria
  • 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
  • White or Caucasian, Black or African American, or Hispanic or Latino/a
  • History of at least one survivorship care visit at the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus 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 the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus of AHWFBCCC
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Exclusion Criteria

Survivors:

  • 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:

  • None
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
SurvivorsCRF Visual AidCancer survivors with any type of cancer seen at the Department of Supportive Oncology (DSO) at the Charlotte campus or the Winston-Salem campus of AHWFBCCC who have completed curative treatment for more than 6 months.
CliniciansCRF Visual AidAny providers working with post-treatment oncology survivors at the DSO at the Charlotte campus or at the Winston Salem campus of AHWFBCCC
Primary Outcome Measures
NameTimeMethod
Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivorsSeven 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.

Secondary Outcome Measures
NameTimeMethod
Qualitative themes derived from open-ended interviews of cliniciansFive months from screening

Qualitative themes resulting from the inductive analysis of open-ended questions administered in clinician interviews. A qualitative theme is the outcome of coding, a label that reflects what a unit of data is about or what it means. Qualitative theme is categorical variable.

Domains reflecting CRF experiences in cancer survivorsSeven months from baseline

Each domain is a binary variable to indicate whether the domain was used or not used.

Appropriateness of the visual aid to alleviate survivor-clinician communication barriersEleven months from baseline

Appropriateness is the degree to which the visual aid addresses patients' needs for communicating CRF and clinicians' needs for assessing CRF. Appropriateness is an ordinal variable.

Trial Locations

Locations (2)

Levine Cancer Institute

🇺🇸

Charlotte, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

🇺🇸

Winston-Salem, North Carolina, United States

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