No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 89
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
134 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for rural cancer survivors experiencing fatigue related to their cancer. Participants will follow a 12-week exercise program remotely, with regular check-ins and assessments throughout the process.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 90 years old.
I have been diagnosed with breast or prostate cancer.
I finished my cancer treatment more than 3 months ago and less than 5 years ago.
I have been experiencing moderate to severe fatigue.
I have high-speed internet at home.
I have a smartphone or laptop with a camera.
I am willing to provide contact information for a support person and a local doctor.
I can give informed consent.
You may not be able to join if
I have an ECOG Performance Status Grade of 2 or higher.
I am currently on cancer treatments or have plans for them in the next six months.
I plan to move to a non-rural location in the next six months.
I have a condition that prevents me from safely exercising.
I have a history of metabolic disease.
I am currently participating in another exercise program for cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 phys…
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.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
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…
Inclusion Criteria:
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.
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.
Exclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status Grade ≥ 2.
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.
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