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

ConditionsCancerFatigue
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to comply with study procedures for the duration of the study

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Survivors1 intervention
Group B: Clinicians1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Seven months from baseline

Secondary outcomes

1

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.

Time frame
Five months from screening
2

Domains reflecting CRF experiences in cancer survivors

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

Time frame
Seven months from baseline
3

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.

Time frame
Eleven months from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator