Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06634381

Conditions

Cancer

Fatigue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CRF Visual Aid

Study Details

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

Study ID

NCT06634381

Start date

Mar 12, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Clinicians

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

Interventions

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.

Primary outcome measure

  • Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors [ Time Frame: Seven months from baseline ]

Central Contacts and Locations

Central contacts

Megan Lattanze

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

Locations

Levine Childrens Hospital Pediatric Cancer and Blood Disorders

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Megan Lattanze

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

Principal Investigator:

Dori Beeler, PhD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Megan Lattanze

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

Principal Investigator:

Dori Beeler, PhD

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Sarah Birken, PhD

336-713-3558sbirken@wakehealth.edu

Principal Investigator:

Sarah Birken, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-24.