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

NCT06634381 | Recruiting DMC

• 2 other identifiers: IRB00119101ONC-CCS-2402
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Fatigue

Outcome Measures

Primary Outcomes (1)

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

  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.

  Seven months from baseline

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: CRF Visual Aid

Clinicians

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

Behavioral: CRF Visual Aid

Interventions

CRF Visual Aid BEHAVIORAL

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.

Clinicians; Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer survivors and clinicians at LCH and/or at the Charlotte or Winston-Salem campuses of AHWFBCCC.

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (3)

Levine Childrens Hospital Pediatric Cancer and Blood Disorders

Charlotte, North Carolina, 28203, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dori Beeler, PhD

  Atrium Health Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lattanze

CONTACT

(980) 442-4239; Megan.Lattanze@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)