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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06634381
Acronym
VAP
Enrollment
80
Registered
2024-10-09
Start date
2025-03-12
Completion date
2028-06-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Fatigue

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.

Interventions

BEHAVIORALCRF 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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
Atrium Health Levine Cancer Institute
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivorsSeven months from baselineA 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

MeasureTime frameDescription
Qualitative themes derived from open-ended interviews of cliniciansFive months from screeningQualitative 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 baselineEach 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 baselineAppropriateness 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.

Countries

United States

Contacts

CONTACTMegan Lattanze
Megan.Lattanze@advocatehealth.org(980) 442-4239
PRINCIPAL_INVESTIGATORDori Beeler, PhD

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026