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NCT Number: NCT06634381

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Levine Cancer Institute, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Seven months from baseline

    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.

Secondary outcomes

  1. Qualitative themes derived from open-ended interviews of clinicians

    Time frame: Five months from screening

    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.

  2. Domains reflecting CRF experiences in cancer survivors

    Time frame: Seven months from baseline

    Each domain is a binary variable to indicate whether the domain was used or not used.

  3. Appropriateness of the visual aid to alleviate survivor-clinician communication barriers

    Time frame: Eleven months from baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Lattanze

CONTACT

[email protected]

(980) 442-4239

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Acronym: VAP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 9, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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