FatigueNCT05684367
Exercise to ReGain Stamina and Energy (The EXERGISE Study)
A study testing Center-Based Walking Exercise and Home-Based Walking Exercise in people with Fatigue and Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. Read more about this study
- Who is it for?
- Ages 60 to 105 years, women only
- Conditions the study is for
- Fatigue, Breast Cancer, Cancer, Therapy-Related
- What is being tested?
- Center-Based Walking Exercise and Home-Based Walking Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to Aug 2026
- Phase
- Interventional
- 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 60 to 105 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate in the study
- Age ≥ 60 years old
- Had stage I-III invasive breast cancer
- The cancer is diagnosed in 2021 or 2022
- Completed adjuvant therapy for at least 3 months but no more than 1 year
- Willingness to participate in all study procedures
- Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)
Who cannot join
- Failure to provide informed consent
- Current involvement in rehabilitation program
- Absolute contraindications to exercise training
- Significant cognitive impairment
- Progressive, degenerative neurologic disease
- Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
Show all 19Show fewer
- Other significant comorbidities that may impair ability to participate in the exercise intervention
- Pregnant
- Regular consumption of nicotinamide riboside supplement
- Simultaneous participation in other interventional studies
- Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
- Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System
- Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
- Receipt of any probiotics within 4 weeks of screening
- History of active treatment for HIV, hepatitis B, or hepatitis C infection
- Positive stool cultures for enteric pathogens, including Clostridium difficile
- Excessive alcohol use (i.e., > 14 drinks/week) or alcohol abuse (i.e., > 5 drinks/day for males or > 4 drinks/day for females)
- Other substance abuse within the past 3 years
- Smoking history in past 3 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute on Aging; University of Florida
Gainesville, Florida, 32611
Stephen D Anton, PhD, 352-273-7514, santon@ufl.edu
Stephen D Anton, PhD
About this study
Official title: Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
Read the detailed description
Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.
In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.
- Conditions
- Fatigue, Breast Cancer, Cancer, Therapy-Related
- Being tested
- Center-Based Walking Exercise, Home-Based Walking Exercise
- Medical subject headings
- Fatigue, Breast Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-Based Walking ExerciseBehavioural
Each exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session.
Home-Based Walking ExerciseBehavioural
Participants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Center-Based Walking Exercise | Experimental | Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study. Receives: Behavioral: Center-Based Walking Exercise |
| Home-Based Walking Exercise | Experimental | Subjects will be randomly assigned to walk for exercise in their community five days/week. Receives: Behavioral: Home-Based Walking Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
Measured: Baseline up to Week 8
Secondary outcomes (10)
Mental Distress (Depression and Anxiety)
Mental distress (depression and anxiety) in past 7 days will be measured by PROMIS. Participants will answer 8 and 7 questions to reflect severity of depression and anxiety, respectively; for each question, a 5-point scale and normalized T-scores will be employed as measure of fatigue.
Measured: Baseline up to Week 8
Self-Reported Pain
Self-reported pain in past 7 days will be measured by 6 questions in PROMIS Pain Interference Short Form; the questions measure severity of pain and use a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much) whose sum can be transformed to a normalized T-score.
Measured: Baseline up to Week 8
Self-Reported Sleep Disturbance
Self-reported sleep short form (8a) that assesses the pure domain of sleep disturbance in individuals aged 18 and older. Each item on the measure is rated on a 5-point scale (1=very good; 2=good; 3=fair; 4=poor; and 5=very poor) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance whose sum can be transformed to a normalized T-score.
Measured: Baseline up to Week 8
Gait Speed
Gait speed will be assessed in by the 6 Minute Walk test, which measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Gait speed will be measured by approach used in the National Health and Nutrition Examination Survey; participants will be asked to finish a 20-foot walking test and gait speed will be calculated as (20×0.3048 meter)/(time (seconds) to finish test).
Measured: Baseline up to Week 8
Physical Function
Physical function will be assessed by the the Short Physical Performance Battery (SPPB). This battery assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test. Additionally, isometric grip strength, a commonly used measure of upper body skeletal function, will be assess with a hand held dynamometer.
Measured: Baseline up to Week 8
Treatment-Induced Peripheral Neuropathy (TIPN)
The 10-item Treatment-induced Neuropathy Assessment Scale (TNAS) will be used to evaluate the severity and impact of peripheral neuropathy on daily functioning at baseline and following or during after chemotherapy treatment. All items are measured based on a 10-point scale. Scores of all items are summed, with higher scores indicating greater neuropathy. Two subscale scores will be calculated to evaluate symptoms related to sensory or interference dimensions. Sensory subscale score will be the mean of 6 sensory items: numbness, tingling, pain, hot or burning, feelings of coldness and disturbed sleep. The interference subscale score - the mean of 3 interference items: trouble walking, trouble with balance and difficulty using hands.
Measured: Baseline up to Week 8
Habitual Physical Activity
Self-administered questionnaire to assess habitual physical activity through three components: work activity, sport activity, and leisure activity. The Modified Baecke Questionnaire measures habitual activity in older adults, which includes questions on household activities, sports and leisure time activities. Free-living physical activity at baseline and follow-up will be measured using an Apple Watch. Adherence to walking exercise intervention will be measured based on four criteria: total walking minutes, total walking minutes within assigned target heart rate zone, percentage of prescribed walking minutes completed per week, and percentage of prescribed walking minutes within the target heart rate zone per week.
Measured: Baseline up to Week 8
Functional Assessment of Cancer Therapy - Breast (FACT-B)
The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer survivors: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). Each item on the measure is rated on a 5 point Likert-type scale (Not at all; A little bit; Somewhat; Quite a bit; and very much).
Measured: Baseline up to Week 8
Perceived Stress
The Perceived Stress Scale (PSS-10) covers feelings and current life situation, both of which are measured on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often); higher scores indicate higher perceived stress.
Measured: Baseline up to Week 8
Dispositional Gratitude
The Gratitude Questionnaire-6 (GQ-6) is designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores range from 6 to 42, with higher scores implying a greater level of dispositional gratitude and lower scores indicating a decreased disposition in gratitude.
Measured: Baseline up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start29 Nov 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (84)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Anton, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684367
- Sponsor's protocol ID
- IRB202202679
- Other IDs
- OCR42286, IRB202102537
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8.
PubMed 30044214Demb J, Abraham L, Miglioretti DL, Sprague BL, O'Meara ES, Advani S, Henderson LM, Onega T, Buist DSM, Schousboe JT, Walter LC, Kerlikowske K, Braithwaite D; Breast Cancer Surveillance Consortium. Screening Mammography Outcomes: Risk of Breast Cancer and Mortality by Comorbidity Score and Age. J Natl Cancer Inst. 2020 Jun 1;112(6):599-606. doi: 10.1093/jnci/djz172.
PubMed 31593591Hamer J, McDonald R, Zhang L, Verma S, Leahey A, Ecclestone C, Bedard G, Pulenzas N, Bhatia A, Chow R, DeAngelis C, Ellis J, Rakovitch E, Lee J, Chow E. Quality of life (QOL) and symptom burden (SB) in patients with breast cancer. Support Care Cancer. 2017 Feb;25(2):409-419. doi: 10.1007/s00520-016-3417-6. Epub 2016 Sep 30.
PubMed 27696078Phillips RO. A review of definitions of fatigue - And a step towards a whole definition. Transport Res F-Traf. 2015;29:48-56.
Campos MPO, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol. 2011 Jun;22(6):1273-1279. doi: 10.1093/annonc/mdq458. Epub 2011 Feb 16.
PubMed 21325448Fu OS, Crew KD, Jacobson JS, Greenlee H, Yu G, Campbell J, Ortiz Y, Hershman DL. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009 Dec;3(4):241-50. doi: 10.1007/s11764-009-0100-7. Epub 2009 Oct 27.
PubMed 19859813Abrahams HJG, Gielissen MFM, Schmits IC, Verhagen CAHHVM, Rovers MM, Knoop H. Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors. Ann Oncol. 2016 Jun;27(6):965-974. doi: 10.1093/annonc/mdw099. Epub 2016 Mar 2.
PubMed 26940687Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
PubMed 10673515Vasbinder A, Reding KW, Wang D, Han CJ, Zaslavsky O, Langford D, Cespedes Feliciano EM, Barrington WE, Paskett ED. Postdiagnosis Physical Activity: Association With Long-Term Fatigue and Sleep Disturbance in Older Adult Breast Cancer Survivors. Clin J Oncol Nurs. 2020 Aug 1;24(4):381-391. doi: 10.1188/20.CJON.381-391.
PubMed 32678375Butt Z, Rao AV, Lai JS, Abernethy AP, Rosenbloom SK, Cella D. Age-associated differences in fatigue among patients with cancer. J Pain Symptom Manage. 2010 Aug;40(2):217-23. doi: 10.1016/j.jpainsymman.2009.12.016. Epub 2010 Jun 11.
PubMed 20541901Egerton T. Self-reported aging-related fatigue: a concept description and its relevance to physical therapist practice. Phys Ther. 2013 Oct;93(10):1403-13. doi: 10.2522/ptj.20130011. Epub 2013 May 23.
PubMed 23704037Zengarini E, Ruggiero C, Perez-Zepeda MU, Hoogendijk EO, Vellas B, Mecocci P, Cesari M. Fatigue: Relevance and implications in the aging population. Exp Gerontol. 2015 Oct;70:78-83. doi: 10.1016/j.exger.2015.07.011. Epub 2015 Jul 17.
PubMed 26190478Bardwell WA, Ancoli-Israel S. Breast Cancer and Fatigue. Sleep Med Clin. 2008 Mar;3(1):61-71. doi: 10.1016/j.jsmc.2007.10.011.
PubMed 18769530Abrahams HJG, Gielissen MFM, Verhagen CAHHVM, Knoop H. The relationship of fatigue in breast cancer survivors with quality of life and factors to address in psychological interventions: A systematic review. Clin Psychol Rev. 2018 Jul;63:1-11. doi: 10.1016/j.cpr.2018.05.004. Epub 2018 May 17.
PubMed 29852324Garabeli Cavalli Kluthcovsky AC, Urbanetz AA, de Carvalho DS, Pereira Maluf EM, Schlickmann Sylvestre GC, Bonatto Hatschbach SB. Fatigue after treatment in breast cancer survivors: prevalence, determinants and impact on health-related quality of life. Support Care Cancer. 2012 Aug;20(8):1901-9. doi: 10.1007/s00520-011-1293-7. Epub 2011 Oct 13.
PubMed 21994001
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05684367
- Acronym / sponsor ID
- IRB202202679
- Conditions
- Fatigue, Breast Cancer, Cancer, Therapy-Related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Jan 2023 (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.
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
Detailed description
Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.
In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center-Based Walking Exercise | Experimental | Behavioral: Center-Based Walking ExerciseSubjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study. |
| Home-Based Walking Exercise | Experimental | Behavioral: Home-Based Walking ExerciseSubjects will be randomly assigned to walk for exercise in their community five days/week. |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consent to participate in the study
- Age ≥ 60 years old
- Had stage I-III invasive breast cancer
- The cancer is diagnosed in 2021 or 2022
- Completed adjuvant therapy for at least 3 months but no more than 1 year
Key exclusion criteria (19 listed)
- Failure to provide informed consent
- Current involvement in rehabilitation program
- Absolute contraindications to exercise training
- Significant cognitive impairment
- Progressive, degenerative neurologic disease
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 |
|---|---|---|
| Center-Based Walking ExerciseEach exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session. | Behavioural | Center-Based Walking Exercise |
| Home-Based Walking ExerciseParticipants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session. | Behavioural | Home-Based Walking Exercise |
Primary outcome
Self-Reported Fatigue
Time frame: Baseline up to Week 8
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
10 secondary outcomes
Mental Distress (Depression and Anxiety)
Time frame: Baseline up to Week 8
Self-Reported Pain
Time frame: Baseline up to Week 8
Self-Reported Sleep Disturbance
Time frame: Baseline up to Week 8
Gait Speed
Time frame: Baseline up to Week 8
Physical Function
Time frame: Baseline up to Week 8
Treatment-Induced Peripheral Neuropathy (TIPN)
Time frame: Baseline up to Week 8
Habitual Physical Activity
Time frame: Baseline up to Week 8
Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: Baseline up to Week 8
Perceived Stress
Time frame: Baseline up to Week 8
Dispositional Gratitude
Time frame: Baseline up to Week 8
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 5 Feb 2026.
- Background: PubMed 30044214Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8.
- Background: PubMed 31593591Demb J, Abraham L, Miglioretti DL, Sprague BL, O'Meara ES, Advani S, Henderson LM, Onega T, Buist DSM, Schousboe JT, Walter LC, Kerlikowske K, Braithwaite D; Breast Cancer Surveillance Consortium. Screening Mammography Outcomes: Risk of Breast Cancer and Mortality by Comorbidity Score and Age. J Natl Cancer Inst. 2020 Jun 1;112(6):599-606. doi: 10.1093/jnci/djz172.
- Background: PubMed 27696078Hamer J, McDonald R, Zhang L, Verma S, Leahey A, Ecclestone C, Bedard G, Pulenzas N, Bhatia A, Chow R, DeAngelis C, Ellis J, Rakovitch E, Lee J, Chow E. Quality of life (QOL) and symptom burden (SB) in patients with breast cancer. Support Care Cancer. 2017 Feb;25(2):409-419. doi: 10.1007/s00520-016-3417-6. Epub 2016 Sep 30.
- BackgroundPhillips RO. A review of definitions of fatigue - And a step towards a whole definition. Transport Res F-Traf. 2015;29:48-56.
- Background: PubMed 21325448Campos MPO, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol. 2011 Jun;22(6):1273-1279. doi: 10.1093/annonc/mdq458. Epub 2011 Feb 16.
- Background: PubMed 19859813Fu OS, Crew KD, Jacobson JS, Greenlee H, Yu G, Campbell J, Ortiz Y, Hershman DL. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009 Dec;3(4):241-50. doi: 10.1007/s11764-009-0100-7. Epub 2009 Oct 27.
- Background: PubMed 26940687Abrahams HJG, Gielissen MFM, Schmits IC, Verhagen CAHHVM, Rovers MM, Knoop H. Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors. Ann Oncol. 2016 Jun;27(6):965-974. doi: 10.1093/annonc/mdw099. Epub 2016 Mar 2.
- Background: PubMed 10673515Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
- Background: PubMed 32678375Vasbinder A, Reding KW, Wang D, Han CJ, Zaslavsky O, Langford D, Cespedes Feliciano EM, Barrington WE, Paskett ED. Postdiagnosis Physical Activity: Association With Long-Term Fatigue and Sleep Disturbance in Older Adult Breast Cancer Survivors. Clin J Oncol Nurs. 2020 Aug 1;24(4):381-391. doi: 10.1188/20.CJON.381-391.
- Background: PubMed 20541901Butt Z, Rao AV, Lai JS, Abernethy AP, Rosenbloom SK, Cella D. Age-associated differences in fatigue among patients with cancer. J Pain Symptom Manage. 2010 Aug;40(2):217-23. doi: 10.1016/j.jpainsymman.2009.12.016. Epub 2010 Jun 11.
- Background: PubMed 23704037Egerton T. Self-reported aging-related fatigue: a concept description and its relevance to physical therapist practice. Phys Ther. 2013 Oct;93(10):1403-13. doi: 10.2522/ptj.20130011. Epub 2013 May 23.
- Background: PubMed 26190478Zengarini E, Ruggiero C, Perez-Zepeda MU, Hoogendijk EO, Vellas B, Mecocci P, Cesari M. Fatigue: Relevance and implications in the aging population. Exp Gerontol. 2015 Oct;70:78-83. doi: 10.1016/j.exger.2015.07.011. Epub 2015 Jul 17.
- 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.
Stephen Anton principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-Based Walking Exercise and Home-Based Walking Exercise in people with Fatigue and Breast Cancer, run by University of Florida at 1 site 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 7 inclusion and 19 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Fatigue (time frame: Baseline up to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684367, which also lists 84 linked publications.
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 5 Feb 2026.