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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Fatigue
• Intervention / Treatment: Behavioral: CRF Visual Aid

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Megan Lattanze; Phone Number: (980) 442-4239; Email: Megan.Lattanze@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Principal Investigator: Dori Beeler, PhD
      • Contact: Megan Lattanze; Phone Number: (980) 442-4239; Email: Megan.Lattanze@advocatehealth.org
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Levine Childrens Hospital Pediatric Cancer and Blood Disorders
      • Principal Investigator: Dori Beeler, PhD
      • Contact: Megan Lattanze; Phone Number: (980) 442-4239; Email: Megan.Lattanze@advocatehealth.org
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Sarah Birken, PhD; Phone Number: 336-713-3558; Email: sbirken@wakehealth.edu
      • Principal Investigator: Sarah Birken, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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
• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Any providers working with post-treatment oncology survivors at LCH and the Charlotte or Winston Salem campuses of AHWFBCCC.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative themes derived from open-ended interviews of clinicians	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.	Five months from screening
Appropriateness of the visual aid to alleviate survivor-clinician communication barriers	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.	Eleven months from baseline
Domains reflecting CRF experiences in cancer survivors	Each domain is a binary variable to indicate whether the domain was used or not used.	Seven months from baseline

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Dori Beeler, PhD, Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Fatigue
• Other Study ID Numbers: IRB00119101; ONC-CCS-2402 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No