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

NCT ID: NCT06634381

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-12

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

CRF Visual Aid

Intervention Type 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

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

CRF Visual Aid

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atrium Health Levine Cancer Institute

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dori Beeler, PhD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Levine Childrens Hospital Pediatric Cancer and Blood Disorders

Charlotte, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Megan Lattanze

Role: CONTACT

(980) 442-4239

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Megan Lattanze

Role: primary

(980) 442-4239

Megan Lattanze

Role: primary

(980) 442-4239

Sarah Birken, PhD

Role: primary

336-713-3558

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONC-CCS-2402

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00119101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain and Fatigue Study
NCT00006253 COMPLETED NA
Cancer Fatigue Education Program
NCT01278147 COMPLETED NA