Cancer SurvivorsCAPABLENCT03750981
C.A.P.A.B.L.E. (CrossFit® and Physical Activity: A Better Life Experience)
A study testing 12 week pilot intervention study. in people with Cancer Survivors, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- 12 week pilot intervention study.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 30 Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older at time of program recruitment
- Diagnosed with any cancer
- Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
- Available transportation to and from the facility on session days
Who cannot join
- Widely metastatic cancers to the brain or bone may be excluded.
- Patients using mobility assistance devices may be excluded. Exclusionary criteria will be reviewed on a case-by-case basis and patients with these limitations may be included with approval from Dr. Beebe-Dimmer and the referring physician.
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
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Tara Baird, (313) 578-4246, bairdt@karmanos.org
About this study
Official title: Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Study of CrossFit® in Cancer Survivors
This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.
Read the detailed description
A 12-week pilot intervention study introducing a high-intensity functional training program to 100 cancer survivors and evaluate the effects of this program on patient quality of life, functional capacity, and body composition. Response rates will be determined using various recruitment methods and estimate differences in response rates by patient characteristics including race, gender and age. Barriers to participation in the program in contacted patients who do not enroll as well as patients who enroll and do not complete the program will be described, as will participant satisfaction with enrolled participants who complete the program. The goal of this pilot study is to help refine the recruitment and program methods for a larger intervention study to test the superiority of a high-intensity interval functional training program compared with current American Cancer Society guidelines in improving functional capacity, body composition and patient reported quality of life.
Surveys will be completed by each participant weekly and physical assessments will be completed monthly.
- Conditions
- Cancer Survivors
- Being tested
- 12 week pilot intervention study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 week pilot intervention study.Behavioural
Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.
| Study group | Role | What they receive |
|---|---|---|
| A 12-week pilot intervention study introducing a high-intensi | Other | Not described Receives: Behavioral: 12 week pilot intervention study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll
Measured: Baseline
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.
Measured: Baseline to 12 weeks
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.
Measured: Baseline to 12 weeks
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.
Measured: Baseline to 12 weeks
Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire
Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in weight in kg
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in body fat percentage
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in visceral fat percentage
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in muscle mass percentage
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2
Measured: Baseline to 12 weeks
Change in Body Composition
Changes in resting metabolism value
Measured: Baseline to 12 weeks
Change in Motivation
Motivation to exercise will be collected via a survey
Measured: Baseline to 12 weeks
Satisfaction with the Program
Satisfaction with the program will be collected via a survey
Measured: 12 weeks
Program Adherence
Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.
Measured: 12 weeks
Height
Height will be collected in meters to use in the calculation of Body Mass Index
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Nov 2018
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Beebe-Dimmer, PhD, Barbara Ann Karmanos Cancer Institute
- Investigators
- Jennifer Beebe-Dimmer, MPH, PhD., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750981
- Sponsor's protocol ID
- 2018-091
- Acronym
- CAPABLE
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2018
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Study of CrossFit® in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03750981
- Acronym / sponsor ID
- CAPABLE / 2018-091
- Conditions
- Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 Nov 2018 (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 will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.
Detailed description
A 12-week pilot intervention study introducing a high-intensity functional training program to 100 cancer survivors and evaluate the effects of this program on patient quality of life, functional capacity, and body composition. Response rates will be determined using various recruitment methods and estimate differences in response rates by patient characteristics including race, gender and age. Barriers to participation in the program in contacted patients who do not enroll as well as patients who enroll and do not complete the program will be described, as will participant satisfaction with enrolled participants who complete the program. The goal of this pilot study is to help refine the recruitment and program methods for a larger intervention study to test the superiority of a high-intensity interval functional training program compared with current American Cancer Society guidelines in improving functional capacity, body composition and patient reported quality of life.
Surveys will be completed by each participant weekly and physical assessments will be completed monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A 12-week pilot intervention study introducing a high-intensi | Other | Behavioral: 12 week pilot intervention study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older at time of program recruitment
- Diagnosed with any cancer
- Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
- Available transportation to and from the facility on session days
Key exclusion criteria (2 listed)
- Widely metastatic cancers to the brain or bone may be excluded.
- Patients using mobility assistance devices may be excluded. Exclusionary criteria will be reviewed on a case-by-case basis and patients with these limitations may be included with approval from Dr. Beebe-Dimmer and the referring physician.
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 |
|---|---|---|
| 12 week pilot intervention study.Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills. | Behavioural | A 12-week pilot intervention study introducing a high-intensi |
Primary outcome
Enrollment rates
Time frame: Baseline
Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Time frame: Baseline to 12 weeks
Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Time frame: Baseline to 12 weeks
Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
Time frame: Baseline to 12 weeks
Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.
Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire
Time frame: Baseline to 12 weeks
Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in weight in kg
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in body fat percentage
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in visceral fat percentage
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in muscle mass percentage
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2
Change in Body Composition
Time frame: Baseline to 12 weeks
Changes in resting metabolism value
Change in Motivation
Time frame: Baseline to 12 weeks
Motivation to exercise will be collected via a survey
Satisfaction with the Program
Time frame: 12 weeks
Satisfaction with the program will be collected via a survey
Program Adherence
Time frame: 12 weeks
Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.
Height
Time frame: Baseline
Height will be collected in meters to use in the calculation of Body Mass Index
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 6 Nov 2025.
- 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.
Jennifer Beebe-Dimmer, MPH, PhD. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 week pilot intervention study. in people with Cancer Survivors, run by Barbara Ann Karmanos Cancer Institute 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 4 inclusion and 2 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 6 Nov 2025. 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?
Contact Jennifer B Beebe-Dimmer, MPH, PhD. ((313) 578-4209, dimmerj@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rates (time frame: Baseline). The study lists 15 primary outcomes in all. 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 6 Nov 2025.