CancerVAPNCT06634381
Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors
An observational study of Cancer and Fatigue, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CRF Visual Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Mar 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer survivors and clinicians at LCH and/or at the Charlotte or Winston-Salem campuses of AHWFBCCC.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- No access to internet/Wi-Fi
- Clinicians:
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Levine Childrens Hospital Pediatric Cancer and Blood Disorders
Charlotte, North Carolina, 28203
Megan Lattanze, (980) 442-4239, Megan.Lattanze@advocatehealth.org
Dori Beeler, PhD
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Megan Lattanze, (980) 442-4239, Megan.Lattanze@advocatehealth.org
Dori Beeler, PhD
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Sarah Birken, PhD, 336-713-3558, sbirken@wakehealth.edu
Sarah Birken, PhD
About this study
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.
Read the 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.
- Being tested
- CRF Visual Aid
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRF Visual AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Survivors | 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. Receives: Behavioral: CRF Visual Aid | |
| Clinicians | Any providers working with post-treatment oncology survivors at LCH and the Charlotte or Winston Salem campuses of AHWFBCCC. Receives: Behavioral: CRF Visual Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven months from baseline
Secondary outcomes (3)
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.
Measured: Five months from screening
Domains reflecting CRF experiences in cancer survivors
Each domain is a binary variable to indicate whether the domain was used or not used.
Measured: Seven months from baseline
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.
Measured: Eleven months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start12 Mar 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Dori Beeler, PhD, Principal investigator, Atrium Health Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634381
- Sponsor's protocol ID
- IRB00119101
- Other IDs
- ONC-CCS-2402
- Acronym
- VAP
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors
- ClinicalTrials.gov ID
- NCT06634381
- Acronym / sponsor ID
- VAP / IRB00119101
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Behavioral: CRF Visual AidCancer 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. |
| Clinicians | – | Behavioral: CRF Visual AidAny providers working with post-treatment oncology survivors at LCH and the Charlotte or Winston Salem campuses of AHWFBCCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer survivors and clinicians at LCH and/or at the Charlotte or Winston-Salem campuses of AHWFBCCC.
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRF Visual AidAfter 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. | Behavioural | Clinicians, Survivors |
Primary outcome
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.
3 secondary outcomes
Qualitative themes derived from open-ended interviews of clinicians
Time frame: Five months from screening
Domains reflecting CRF experiences in cancer survivors
Time frame: Seven months from baseline
Appropriateness of the visual aid to alleviate survivor-clinician communication barriers
Time frame: Eleven months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dori Beeler, PhD principal investigator
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Fatigue, run by Wake Forest University Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Lattanze ((980) 442-4239, Megan.Lattanze@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Domains reflecting cancer-related fatigue (CRF) experiences in cancer survivors (time frame: Seven months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.