Endometrial CancerNCT07283029
Activity and Cancer Survivorship Exercise Pilot
A study testing Functional fitness following home-based comprehensive exercise program in people with Endometrial Cancer, run by University of Iowa at 1 site in United States.
Trial summary
This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Functional fitness following home-based comprehensive exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to Dec 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 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide written informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Fluent in spoken and written English
- Women 18-74 years of age
- Documented diagnosis of type I, stage I-IIIc endometrial cancer within the past 5 years
- Completion of current treatment for endometrial cancer
- Technology access (cellphone with data, broadband internet, WiFi) for tele coaching
- Pass the Physical Activity Readiness Questionnaire (PAR-Q)
Who cannot join
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
- Have evidence of recurrent or metastatic disease
- Are currently performing resistance training >= 2 days per week
- Are currently exceeding 150 minutes of at least moderate intensity activity per week
- Report of chest pain, shortness of breath, fainting, or angina pectoris
- Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
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- Plans to move from the area
- Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
- Women who are pregnant or breast-feeding
- Not suitable for study participation due to other reasons at the discretion of the investigator
- Failing the Physical Activity Readiness Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Changes in Functional Fitness Following a 10-Week Home-Based Comprehensive Exercise Program in Endometrial Cancer Patients Who Have Completed Treatment
This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.
- Conditions
- Endometrial Cancer
- Being tested
- Functional fitness following home-based comprehensive exercise program
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional fitness following home-based comprehensive exercise programOther
Patients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Not described Receives: Other: Functional fitness following home-based comprehensive exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chair sit to stand test
Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test
Measured: baseline, pre-intervention and immediately after the intervention
Secondary outcomes (7)
Incidence of adverse events
Will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, [NCI CTCAE v 5.0] grades), and relation to study treatment. The most severe grade per patient will be reported.
Measured: Up to 10 weeks
Muscle strengthening exercise session adherence
Exercise session adherence will be defined as the proportion of planned exercise sessions in which a participant completes at least 50% of the prescribed exercises. The mean and associated 90% confidence interval will be reported
Measured: Up to 10 weeks
Aerobic physical activity adherence
Aerobic physical activity adherence will be defined as the proportion of planned weeks a participant accumulates 150 minutes of moderate intensity activity. The mean and associated 90% confidence interval will be reported.
Measured: Up to 10 weeks
Tele coaching adherence
Tele coaching adherence will be defined as the proportion of planned exercise sessions in which a participant completes. The mean and associated 90% confidence interval will be reported.
Measured: Up to 10 weeks
Exercise program acceptability
Acceptability will be assessed using Likert scale ratings of quality of exercise equipment, educational materials, health coaching, study feedback and distance-delivery format. Means and associated 90% confidence intervals will be reported for each item.
Measured: Up to 10 weeks
Body weight
Will be assessed by the within patient change of weight, waist and hip circumferences will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in anthropometrics. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary secondary outcome is changes in weight.
Measured: baseline, pre-intervention and immediately after the intervention
Ambulatory activity levels
Will be assessed by the within patient change in average daily steps taken within a week will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in ambulatory activity levels. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean and associated 90% confidence interval will be reported.
Measured: baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start9 Feb 2023
- Primary completion6 Dec 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Jess S. Gorzelitz, University of Iowa
- Investigators
- Jessica Gorzelitz, PhD, Principal investigator, University of Iowa Holden Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283029
- Sponsor's protocol ID
- 202212082
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Changes in Functional Fitness Following a 10-Week Home-Based Comprehensive Exercise Program in Endometrial Cancer Patients Who Have Completed Treatment
- ClinicalTrials.gov ID
- NCT07283029
- Acronym / sponsor ID
- 202212082
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Dec 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 early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Functional fitness following home-based comprehensive exercise program |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to provide written informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Fluent in spoken and written English
- Women 18-74 years of age
- Documented diagnosis of type I, stage I-IIIc endometrial cancer within the past 5 years
Key exclusion criteria (11 listed)
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
- Have evidence of recurrent or metastatic disease
- Are currently performing resistance training >= 2 days per week
- Are currently exceeding 150 minutes of at least moderate intensity activity per week
- Report of chest pain, shortness of breath, fainting, or angina pectoris
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 |
|---|---|---|
| Functional fitness following home-based comprehensive exercise programPatients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study. | Other | Exercise Intervention |
Primary outcome
Chair sit to stand test
Time frame: baseline, pre-intervention and immediately after the intervention
Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test
7 secondary outcomes
Incidence of adverse events
Time frame: Up to 10 weeks
Muscle strengthening exercise session adherence
Time frame: Up to 10 weeks
Aerobic physical activity adherence
Time frame: Up to 10 weeks
Tele coaching adherence
Time frame: Up to 10 weeks
Exercise program acceptability
Time frame: Up to 10 weeks
Body weight
Time frame: baseline, pre-intervention and immediately after the intervention
Ambulatory activity levels
Time frame: baseline, pre-intervention and immediately after the intervention
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 15 Dec 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. This study is not recruiting at the moment.
Jessica Gorzelitz, PhD principal investigator
University of Iowa Holden Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional fitness following home-based comprehensive exercise program in people with Endometrial Cancer, run by University of Iowa 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chair sit to stand test (time frame: baseline, pre-intervention and immediately after the intervention). 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 15 Dec 2025.