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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Cancer; Fatigue

Treatments: Behavioral: CRF Visual Aid

Study type: Observational

Funder types: Other

Identifiers

NCT06634381

ONC-CCS-2402 (Other Identifier)

IRB00119101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Survivors

Description:

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.

Treatment:

Behavioral: CRF Visual Aid

Clinicians

Description:

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

Treatment:

Behavioral: CRF Visual Aid