Clinical trial NCT06634381: Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors
Official title: Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Fatigue
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2024-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer survivors and clinicians from the Department of Supportive Oncology at the Charlotte campus or the Survivorship Clinic at the Winston-Salem campus of AHWFBCCC.

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.

Eligibility criteria: 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 survivorship care visit at the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus 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 the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus 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

Primary outcomes:
measure: Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors
timeFrame: Seven months from baseline
Secondary outcomes:
measure: Qualitative themes derived from open-ended interviews of clinicians
timeFrame: Five months from screening
measure: Domains reflecting CRF experiences in cancer survivors
timeFrame: Seven months from baseline
measure: Appropriateness of the visual aid to alleviate survivor-clinician communication barriers
timeFrame: Eleven months from baseline
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
name: Dori Beeler, PhD
role: PRINCIPAL_INVESTIGATOR
References: