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RecruitingPhase 2

Telehealth Exercise Program Evaluating Fatigue and Physical Function in Rural Cancer Survivors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Small dried blood samples and measures of physical function will be collected throughout the program."
  • "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."
  • "Small blood samples are collected before and after a standardized treadmill exercise session."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 12-week exercise program done online can ease cancer-related tiredness and improve physical function. It is for adults in rural areas who have had breast or prostate cancer and have at least moderate tiredness. Some people will wait 12 weeks before starting the program.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 89 and have a diagnosis of breast or prostate cancer.
  • Have finished treatment meant to cure the cancer more than 3 months but less than 5 years before the study starts. Treatment must have included hormone therapy, radiation, chemotherapy, or immunotherapy—not surgery alone.
  • People with breast cancer may still receive ongoing hormone therapy if no treatment changes are planned for the next 6 months.
  • Live in an area counted as rural under federal guidelines and have tiredness rated above 3 out of 10.
  • Have high-speed home internet and a smartphone or laptop with a front-facing camera.
  • Be able and willing to agree to join after learning about the study. Agree to the 12-week online exercise program, with a possible 12-week wait first, plus brief online physical checks and home blood spot samples every 2 weeks.
  • Provide contact details for a nearby support person and a local primary care provider who can help if health problems arise.
  • Provide signed permission from a doctor to exercise if the study's safety checks require it.

Who can't join

  • Have an ECOG score of 2 or higher, meaning health limits daily activity enough that you cannot work, or need more help with daily care.
  • Be receiving or planning cancer treatment in the next 6 months, except ongoing hormone therapy allowed by the study.
  • For prostate cancer: be receiving androgen deprivation therapy (ADT), which lowers male hormones, or have received it for a total of 12 months or more.
  • Plan to move to an area that is not rural in the next 6 months.
  • Have a condition that makes exercise unsafe, such as a recent heart problem or chronic obstructive pulmonary disease, a long-term lung disease.
  • Have or have had a disease that affects how the body uses energy, such as diabetes or an uncontrolled thyroid condition. Pre-diabetes, metabolic syndrome, and diabetes treated only with metformin are allowed.
  • Be taking part in another exercise program for people with cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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, 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.

Study sites (2)

CO

MT