Cancer-related FatiguePhase 2NCT07001241
Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors
A Phase 2 study testing Telehealth Exercise Program in people with Cancer-related Fatigue and Breast Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). Small dried blood samples and measures of physical function will be collected throughout the program. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cancer-related Fatigue, Breast Cancer, Prostate Cancer
- What is being tested?
- Telehealth Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2025to Dec 2030
- Phase
- Phase 2
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 and < 90 years of age. 2. Diagnosis of breast or prostate cancer. 3. Cancer treatment criteria: 3a. Completion of treatment with curative intent > 3 months prior to and < 5 years from study initiation.
- 3b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
- 3c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
- 4. Home zip code meeting Health Resources \& Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
- 5. Presence of at least moderate fatigue (>3/10 per National Comprehensive Cancer Network guidelines).
- 6. Access to high-speed home internet. 7. Possession of smartphone or laptop with front-facing camera. 8. Capable and willing to give informed consent. 9. Willing to participate in a 12-week telehealth exercise intervention or 12-week waiting period prior to intervention with brief remote physical assessments and dried blood spot collection every 2 weeks.
Show all 9Show fewer
- 10. Able and willing to provide contact information for a local support individual to assist with any possible adverse events.
- 11. Able and willing to provide contact information for a local primary care provider to address medical issues potentially arising during study activities.
- 12. Able to provide signed physician clearance for exercise if indicated by the Physical Activity Readiness Questionnaire (PAR-Q+) or National Comprehensive Cancer Network exercise safety screening questions.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
- Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
- 2a. For individuals with a prostate cancer diagnosis, those currently receiving androgen deprivation therapy (ADT), or those who have previously received ≥ 12 months of ADT, are not eligible.
- 3. Plans to relocate to a non-rural location in the next six months. 4. Presence of a disease or condition that affects the ability of an individual to safely participate in an exercise intervention (e.g. recent cardiac event or chronic obstructive pulmonary disease).
- 4a. These conditions are identified in the PAR-Q+. 5. Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
- 5a. Participants with pre-diabetes, metabolic syndrome, or diabetes managed with metformin only will be eligible, with this variable tracked for later analysis.
- 6. Current participation in another exercise oncology program.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Jared Scorsone, 720-724-9601, Jared.Scorsone@cuanshutz.edu
Ryan J Marker, PhD, DPT
- Recruiting
University of Montana
Missoula, Montana, 59812
John C Quindry, PhD, 406-243-4268, john.quindry@mso.umt.edu
John C Quindry, PhD
About this study
Official title: Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). Small dried blood samples and measures of physical function will be collected throughout the program. The main questions it aims to answer are:
- Does the exercise program improve CRF in rural cancer survivors?
- How do CRF, metabolism, and physical function change during the exercise program? Researchers will compare the program to a wait-list control group. This group will complete all study measures without without changing current physical activity before receiving the full exercise program.
Read more
Participants will:
- Complete a virtual physical assessment before and after the program.
- Complete brief virtual assessments and collect dried blood samples (at home and mailed in) every two weeks during the program.
- Receive a personalized exercise program including virtual sessions and remote exercise programming with a cancer exercise specialist (after a 12-week wait period in the wait-list control group).
- Optional: Willing participants will visit a study site for a laboratory-based exercise assessment before and after the program.
Read the detailed description
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). The 12-week program is designed to be delivered completely via remote methods including: telehealth exercise sessions with cancer exercise specialists, additional exercise programming delivered through a personal training smartphone/internet application, and regular symptom monitoring via emailed surveys. Symptoms (CRF) are plotted against a reference chart of anticipated changes during the program, with additional telehealth sessions initiated if symptoms do not improve as predicted. Program efficacy is investigated using a randomized controlled trial with a wait-list control group (N=134, Aim 1). The control group will receive the exercise program following a 12-week wait period.
Possible mechanisms of action are assessed throughout the program (every two weeks) using accessible methods (Aim 2). Fatty acid oxidation is measured via dried blood spots collected remoted and mailed to the primary study site. Physical function is measured via brief telehealth assessments.
Changes in molecular responses to acute exercise and changes in body composition will be explored in a controlled laboratory assessment in participants able and willing to travel to participating sites (N=40, Aim 3). Small blood samples are collected before and after a standardized treadmill exercise session. Body composition is measured non-invasively in a small chamber using air displacement. This laboratory assessment occurs before and after the program (or wait period).
- Conditions
- Cancer-related Fatigue, Breast Cancer, Prostate Cancer
- Being tested
- Telehealth Exercise Program
- Keywords
- Prostate Cancer, Exercise, Telehealth, Breast Cancer, Metabolism, Physical function
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Exercise ProgramBehavioural
Also called BfitBwell Telehealth Program (BfitBwell-TP)
BfitBwell-TP is a 12-week telehealth exercise intervention. Exercise prescriptions are created, personalized, and delivered by Cancer Exercise Specialists. Exercise content is delivered using a combination of videoconference sessions and a commercial personal training application (accessible via smartphone or internet browser). Patient-reported symptoms (specifically cancer-related fatigue) are assessed every two weeks via emailed surveys. Survey scores are compared to a reference chart of predicted improvements during the program, developed from an established clinical exercise oncology program. Additional videoconference sessions are initiated for participants demonstrating lower than expected symptom improvement, with the goal of adapting the current exercise prescription to improve symptom response.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Exercise Program | Experimental | The BfitBwell-TP (Telehealth Program) intervention is designed specifically for rural cancer survivors with cancer-related fatigue (CRF). It is personalized to each participant, addresses known barriers to exercise participation in rural survivors, and incorporates the experience and infrastructure of the established clinical BfitBwell Cancer Exercise Program. BfitBwell-TP is delivered completely via existing and accessible telehealth technologies including: videoconference sessions with a cancer exercise specialist, exercise programming and text communication using a personal training smartphone/internet application, and emailed surveys. CRF is assessed throughout the program with additional telehealth sessions initiated if it does not improve as predicted based on a reference chart developed with BfitBwell data. Receives: Behavioral: Telehealth Exercise Program |
| Waitlist Control Group | No intervention | This group will be instructed to not change their current physical activity and exercise routines while completing all study assessments (including brief assessments every two weeks). After completing a final assessment following the 12-week wait period, they will receive the full exercise intervention (see Experimental Arm for description). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12
The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.
Measured: Baseline, Week 12
Secondary outcomes (27)
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 24
The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.
Measured: Baseline, Week 24
Change from Baseline in FACT-G (quality of life) score at Week 12
The Functional Assessment of Cancer Treatment - General scale (FACTG-G) is a common standardized measure of quality of life in cancer survivors. It contains 27 items with total score ranging from 0 to 108, with higher scores indicating better quality of life.
Measured: Baseline, Week 12
Pattern of change in FACIT-Fatigue (cancer-related fatigue) score during exercise intervention or wait period
The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.
Scores will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Change from Baseline in FACT-G (quality of life) score at Week 24
The Functional Assessment of Cancer Treatment - General scale (FACTG-G) is a common standardized measure of quality of life in cancer survivors. It contains 27 items with total score ranging from 0 to 108, with higher scores indicating better quality of life.
Measured: Baseline, Week 24
Change from Baseline in HADS (anxiety and depression) scores at Week 12
The Hospital Anxiety and Depression Scale (HADS) is a common standardized measure of anxiety and depression in clinical populations. It contains 14 items yielding Anxiety and Depression scores. Scores range from 0 to 21, with higher scores indicating more anxiety or depressive symptoms.
Measured: Baseline, Week 12
Change from Baseline in HADS (anxiety and depression) scores at Week 24
The Hospital Anxiety and Depression Scale (HADS) is a common standardized measure of anxiety and depression in clinical populations. It contains 14 items yielding Anxiety and Depression scores. Scores range from 0 to 21, with higher scores indicating more anxiety or depressive symptoms.
Measured: Baseline, Week 24
Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 12
The European Organisation for Research and Treatment of Cancer Group Quality of Life Questionnaire Fatigue 12 (EORTC QLQ-FA12) is a recently developed measure of cancer-related fatigue with multiple subscales (physical fatigue, emotional fatigue, and cognitive fatigue). It contains 12 items, with scores ranging from 0 to 100, and higher scores indicating higher fatigue symptoms.
Measured: Baseline, Week 12
Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 24
The European Organisation for Research and Treatment of Cancer Group Quality of Life Questionnaire Fatigue 12 (EORTC QLQ-FA12) is a recently developed measure of cancer-related fatigue with multiple subscales (physical fatigue, emotional fatigue, and cognitive fatigue). It contains 12 items, with scores ranging from 0 to 100, and higher scores indicating higher fatigue symptoms.
Measured: Baseline, Week 24
Change from Baseline in 2MST (physical function) at Week 12
The Two-Minute Step Test (2MST) is a submaximal test of aerobic capacity. Participants step in place for two minutes, raining each knee to a pre-specified height. Final measure is number of steps performed, with more steps indicating higher aerobic capacity.
Measured: Baseline, Week 12
Change from Baseline in CS (physical function) at Week 12
The Chair Stand Test (CS) is an assessment of lower extremity function and muscular strength. Participants move from a seated position to standing and back as many times as possible in 30 s. Final measure is number of completed stands, with more stands indicating higher muscular strength and function.
Measured: Baseline, Week 12
Change from Baseline in GS (physical function) at Week 12
Gait Speed (GS) is a common clinical measure of physical function. Participants are timed while walking at a 'usual' pace for 4 m. Final measure is m/s, with faster speeds indicating higher function.
Measured: Baseline, Week 12
Change from Baseline in TUG (physical function) at Week 12
The Timed Up and Go test (TUG) is a common clinical measure of physical function. Participants are timed while standing from a chair, walking 3 m, turning around, and returning to sit in the chair. Final measure is time to perform, with lower times indicating higher function.
Measured: Baseline, Week 12
Change from Baseline in SLB (physical function) at Week 12
Single Leg Balance (SLB) is a common clinical measure of balance and physical function. Participants are timed while standing on one leg with no external support (for up to 30 s). Final measure is time able to balance, with higher times indicating higher function.
Measured: Baseline, Week 12
Change from Baseline in daily physical activity (PA) at Week 12
Daily physical activity will be assessed for a 7-day period and calculated as average steps/day. This will be collected with a study provided commercial activity tracker.
Measured: Baseline, Week 12
Change from Baseline in average sleep time at Week 12
Sleep time, assessed as time in bed at night, will be assessed over a 7-day period and averaged. This will be measured with a study provided commercial fitness tracker.
Measured: Baseline, Week 12
Change from Baseline in fatty acid oxidation at Week 12
Fatty acid oxidation will be calculated as the ratio of medium- to long-chain acylcarnitines in metabolomic and lipidomic data acquired from high-throughput liquid chromatography-mass spectrometry. Samples are collected remotely as dried blood spots and mailed to the primary study site.
Measured: Baseline, Week 12
Change from Baseline in dynamic exercise metabolic profiles at Week 12
This measure is optional and performed at a participating study site. Small blood samples are collected before, after, and 30 min after a standard 36 min moderate intensity treadmill walking session. Dynamic metabolic profiles will be investigated by comparing analyses from the different timepoints (e.g. before-to-after exercise, recovery from after-to-30 minutes after exercise, etc.), using metabolomic and lipidomic data acquired from the collected samples via high-throughput liquid chromatography-mass spectrometry.
Measured: Baseline, Week 12
Change from Baseline in body composition at Week 12
This measure is optional, performed during assessments at a participating study site. Body composition is measured while participants sit in a small, closed chamber for approximately two minutes, via air displacement plethysmography. The measure is presented as percent fat mass and percent lean mass.
Measured: Baseline, Week 12
Pattern of change in FACT-G (quality of life) score during exercise intervention or wait period
The Functional Assessment of Cancer Treatment - General scale (FACTG-G) is a common standardized measure of quality of life in cancer survivors. It contains 27 items with total score ranging from 0 to 108, with higher scores indicating better quality of life.
Scores will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in HADS (anxiety and depression) scores during exercise intervention or wait period
The Hospital Anxiety and Depression Scale (HADS) is a common standardized measure of anxiety and depression in clinical populations. It contains 14 items yielding Anxiety and Depression scores. Scores range from 0 to 21, with higher scores indicating more anxiety or depressive symptoms.
Scores will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in EORTC QLQ-FA12 (cancer-related fatigue) scores during exercise intervention or wait period
The European Organisation for Research and Treatment of Cancer Group Quality of Life Questionnaire Fatigue 12 (EORTC QLQ-FA12) is a recently developed measure of cancer-related fatigue with multiple subscales (physical fatigue, emotional fatigue, and cognitive fatigue). It contains 12 items, with scores ranging from 0 to 100, and higher scores indicating higher fatigue symptoms.
Scores will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in 2MST (physical function) during exercise intervention or wait period
The Two-Minute Step Test (2MST) is a submaximal test of aerobic capacity. Participants step in place for two minutes, raining each knee to a pre-specified height. Final measure is number of steps performed, with more steps indicating higher aerobic capacity.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in CS (physical function) during exercise intervention or wait period
The Chair Stand Test (CS) is an assessment of lower extremity function and muscular strength. Participants move from a seated position to standing and back as many times as possible in 30 s. Final measure is number of completed stands, with more stands indicating higher muscular strength and function.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in GS (physical function) during exercise intervention or wait period
Gait Speed (GS) is a common clinical measure of physical function. Participants are timed while walking at a 'usual' pace for 4 m. Final measure is m/s, with faster speeds indicating higher function.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in TUG (physical function) during exercise intervention or wait period
The Timed Up and Go test (TUG) is a common clinical measure of physical function. Participants are timed while standing from a chair, walking 3 m, turning around, and returning to sit in the chair. Final measure is time to perform, with lower times indicating higher function.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in SLB (physical function) during exercise intervention or wait period
Single Leg Balance (SLB) is a common clinical measure of balance and physical function. Participants are timed while standing on one leg with no external support (for up to 30 s). Final measure is time able to balance, with higher times indicating higher function.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in fatty acid oxidation during exercise intervention or wait period
Fatty acid oxidation will be calculated as the ratio of medium- to long-chain acylcarnitines in metabolomic and lipidomic data acquired from high-throughput liquid chromatography-mass spectrometry. Samples are collected remotely as dried blood spots and mailed to the primary study site.
Measure will be collected every two weeks during the intervention (or wait period) and change patterns established as the changes between adjacent timepoints.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start8 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to an intervention group or wait-list control group. Participants in both groups complete all study assessments (primary outcomes). Following all study assessments with no intervention, participants in the wait-list control group will receive the full exercise program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryan J Marker, PhD, DPT, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001241
- Sponsor's protocol ID
- 24-1398.cc
- Other IDs
- R01CA292482
- Status last verified
- Feb 2026
- First submitted
- 23 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified research outcomes data and protocols will be made upon request, at the study PI's discretion.
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
- Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
- ClinicalTrials.gov ID
- NCT07001241
- Acronym / sponsor ID
- 24-1398.cc
- Conditions
- Cancer-related Fatigue, Breast Cancer, Prostate Cancer
- Keywords
- Prostate Cancer, Exercise, Telehealth, Breast Cancer, Metabolism, Physical function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Jun 2025 (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.
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). Small dried blood samples and measures of physical function will be collected throughout the program. The main questions it aims to answer are:
- Does the exercise program improve CRF in rural cancer survivors?
- How do CRF, metabolism, and physical function change during the exercise program? Researchers will compare the program to a wait-list control group. This group will complete all study measures without without changing current physical activity before receiving the full exercise program.
Participants will:
- Complete a virtual physical assessment before and after the program.
- Complete brief virtual assessments and collect dried blood samples (at home and mailed in) every two weeks during the program.
- Receive a personalized exercise program including virtual sessions and remote exercise programming with a cancer exercise specialist (after a 12-week wait period in the wait-list control group).
- Optional: Willing participants will visit a study site for a laboratory-based exercise assessment before and after the program.
Detailed description
This study investigates the efficacy of a telehealth exercise program designed specifically for rural cancer survivors with cancer-related fatigue (CRF). The 12-week program is designed to be delivered completely via remote methods including: telehealth exercise sessions with cancer exercise specialists, additional exercise programming delivered through a personal training smartphone/internet application, and regular symptom monitoring via emailed surveys. Symptoms (CRF) are plotted against a reference chart of anticipated changes during the program, with additional telehealth sessions initiated if symptoms do not improve as predicted. Program efficacy is investigated using a randomized controlled trial with a wait-list control group (N=134, Aim 1). The control group will receive the exercise program following a 12-week wait period.
Possible mechanisms of action are assessed throughout the program (every two weeks) using accessible methods (Aim 2). Fatty acid oxidation is measured via dried blood spots collected remoted and mailed to the primary study site. Physical function is measured via brief telehealth assessments.
Changes in molecular responses to acute exercise and changes in body composition will be explored in a controlled laboratory assessment in participants able and willing to travel to participating sites (N=40, Aim 3). Small blood samples are collected before and after a standardized treadmill exercise session. Body composition is measured non-invasively in a small chamber using air displacement. This laboratory assessment occurs before and after the program (or wait period).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to an intervention group or wait-list control group. Participants in both groups complete all study assessments (primary outcomes). Following all study assessments with no intervention, participants in the wait-list control group will receive the full exercise program.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Exercise Program | Experimental | Behavioral: Telehealth Exercise ProgramThe BfitBwell-TP (Telehealth Program) intervention is designed specifically for rural cancer survivors with cancer-related fatigue (CRF). It is personalized to each participant, addresses known barriers to exercise participation in rural survivors, and incorporates the experience and infrastructure of the established clinical BfitBwell Cancer Exercise Program. BfitBwell-TP is delivered completely via existing and accessible telehealth technologies including: videoconference sessions with a cancer exercise specialist, exercise programming and text communication using a personal training smartphone/internet application, and emailed surveys. CRF is assessed throughout the program with additional telehealth sessions initiated if it does not improve as predicted based on a reference chart developed with BfitBwell data. |
| Waitlist Control Group | No intervention | –This group will be instructed to not change their current physical activity and exercise routines while completing all study assessments (including brief assessments every two weeks). After completing a final assessment following the 12-week wait period, they will receive the full exercise intervention (see Experimental Arm for description). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ≥ 18 and < 90 years of age. 2. Diagnosis of breast or prostate cancer. 3. Cancer treatment criteria: 3a. Completion of treatment with curative intent > 3 months prior to and < 5 years from study initiation.
- 3b. Treatment must include hormonal, radiation, chemotherapy, and/or immunotherapy. Those who have received only surgery are not eligible.
- 3c. Individuals diagnosed with breast cancer currently receiving maintenance hormonal therapy, with no planned treatment changes in the next six months, are eligible.
- 4. Home zip code meeting Health Resources \& Services Administration (HRSA) definition of rural (data.hrsa.gov/tools/rural-health).
- 5. Presence of at least moderate fatigue (>3/10 per National Comprehensive Cancer Network guidelines).
Key exclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
- Current or planned cancer-related treatments (except maintenance hormonal therapies) in the next six months.
- 2a. For individuals with a prostate cancer diagnosis, those currently receiving androgen deprivation therapy (ADT), or those who have previously received ≥ 12 months of ADT, are not eligible.
- 3. Plans to relocate to a non-rural location in the next six months. 4. Presence of a disease or condition that affects the ability of an individual to safely participate in an exercise intervention (e.g. recent cardiac event or chronic obstructive pulmonary disease).
- 4a. These conditions are identified in the PAR-Q+. 5. Presence or history of metabolic disease (e.g. diabetes or uncontrolled hyper- or hypothyroidism).
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 |
|---|---|---|
| Telehealth Exercise ProgramAlso: BfitBwell Telehealth Program (BfitBwell-TP)BfitBwell-TP is a 12-week telehealth exercise intervention. Exercise prescriptions are created, personalized, and delivered by Cancer Exercise Specialists. Exercise content is delivered using a combination of videoconference sessions and a commercial personal training application (accessible via smartphone or internet browser). Patient-reported symptoms (specifically cancer-related fatigue) are assessed every two weeks via emailed surveys. Survey scores are compared to a reference chart of predicted improvements during the program, developed from an established clinical exercise oncology program. Additional videoconference sessions are initiated for participants demonstrating lower than expected symptom improvement, with the goal of adapting the current exercise prescription to improve symptom response. | Behavioural | Telehealth Exercise Program |
Primary outcome
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12
Time frame: Baseline, Week 12
The Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) is a common standardized measure of cancer-related fatigue. It contains 13 items with total score ranging from 0 to 52, with higher scores indicating less fatigue.
27 secondary outcomes
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 24
Time frame: Baseline, Week 24
Change from Baseline in FACT-G (quality of life) score at Week 12
Time frame: Baseline, Week 12
Pattern of change in FACIT-Fatigue (cancer-related fatigue) score during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Change from Baseline in FACT-G (quality of life) score at Week 24
Time frame: Baseline, Week 24
Change from Baseline in HADS (anxiety and depression) scores at Week 12
Time frame: Baseline, Week 12
Change from Baseline in HADS (anxiety and depression) scores at Week 24
Time frame: Baseline, Week 24
Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 12
Time frame: Baseline, Week 12
Change from Baseline in EORTC QLQ-FA12 (cancer-related fatigue) scores at Week 24
Time frame: Baseline, Week 24
Change from Baseline in 2MST (physical function) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in CS (physical function) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in GS (physical function) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in TUG (physical function) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in SLB (physical function) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in daily physical activity (PA) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in average sleep time at Week 12
Time frame: Baseline, Week 12
Change from Baseline in fatty acid oxidation at Week 12
Time frame: Baseline, Week 12
Change from Baseline in dynamic exercise metabolic profiles at Week 12
Time frame: Baseline, Week 12
Change from Baseline in body composition at Week 12
Time frame: Baseline, Week 12
Pattern of change in FACT-G (quality of life) score during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in HADS (anxiety and depression) scores during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in EORTC QLQ-FA12 (cancer-related fatigue) scores during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in 2MST (physical function) during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in CS (physical function) during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in GS (physical function) during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in TUG (physical function) during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in SLB (physical function) during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
Pattern of change in fatty acid oxidation during exercise intervention or wait period
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12
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.
- Individual participant dataSharing planned: Yes. De-identified research outcomes data and protocols will be made upon request, at the study PI's discretion.
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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.
Ryan J Marker, PhD, DPT principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telehealth Exercise Program in people with Cancer-related Fatigue and Breast Cancer, run by University of Colorado, Denver at 2 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 9 inclusion and 7 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 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jared Scorsone (720-724-9601, Jared.Scorsone@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in FACIT-Fatigue (cancer-related fatigue) score at Week 12 (time frame: Baseline, Week 12). 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 5 Feb 2026.