Breast CancerNCT07765927
Exercise Oncology Clinic Pilot Feasibility Trial
A study testing Supervised, Personalized Exercise Program in people with Breast Cancer and Gynecologic Cancer, run by Jess S. Gorzelitz at 1 site in United States.
Trial summary
The purpose of this pilot study is to test a supervised exercise program for adults with a history of breast or gynecologic cancer to see if it is safe, helpful, and easy to take part in. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Supervised, Personalized Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 15 Apr 2027
- 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
- Age ≥18 years
- Confirmed diagnosis of breast or gynecologic cancer (any stage)
- Willingness to participate in the exercise oncology program and associated research procedures Ability to provide informed consent
- Clearance to participate in exercise as determined by completion of the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and any additional clinical screening as needed
Who cannot join
- Presence of absolute contraindications to exercise (e.g., unstable cardiovascular disease, acute illness, or other conditions that preclude safe participation in physical activity)
- Determination by a referring or treating healthcare provider that the patient is not appropriate for exercise participation at the time of screening
- Inability to complete required screening procedures, including the PAR-Q+
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
University of Iowa Health Care
Iowa City, Iowa, 52242
Jess Gorzelitz, PhD, MS, (319) 467-0849, jess-gorzelitz@uiowa.edu
About this study
Official title: Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients
The purpose of this pilot study is to test a supervised exercise program for adults with a history of breast or gynecologic cancer to see if it is safe, helpful, and easy to take part in.
Read the detailed description
This pilot study will enroll up to 30 adult cancer patients to participate in a structured exercise oncology clinic to evaluate and refine clinical procedures for individualized exercise assessment and prescription. The study is designed to generate preliminary data on the feasibility, acceptability, and safety of implementing a supervised exercise program integrated into oncology care.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Supervised, Personalized Exercise Program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised, Personalized Exercise ProgramOther
Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.
| Study group | Role | What they receive |
|---|---|---|
| Supervised, Personalized Exercise Program | Experimental | The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices. Receives: Other: Supervised, Personalized Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
Recruitment rate will be reported as a proportion (percentage) each month
Measured: Recruitment period which will start at day 1 through two months
Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment.
Retention rate will be reported as a proportion (percentage)
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions.
Summarized as mean adherence (%) and proportion meeting predefined adherence thresholds (e.g., >70%;>80%).
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments.
All feasibility outcomes will be summarized using descriptive statistics (means, standard deviations, medians, ranges, and proportions with 95% confidence intervals where appropriate).
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Secondary outcomes (4)
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
Satisfaction survey responses summarized as means and distributions across response categories.
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Participant perceived burden (e.g., time, effort, difficulty) reported descriptively and categorized (low/moderate/high burden)
Perceived burden survey responses reported descriptively and categorized (low/moderate/high burden)
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.
Proportion of participant endorsement of exercising or continuing exercise programming.
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
Participant qualitative feedback summarized by brief theme categorization,
Measured: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start3 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jess S. Gorzelitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jess S. Gorzelitz, University of Iowa
- Investigators
- Jess Gorzelitz, PhD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765927
- Sponsor's protocol ID
- 202508370
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients
- ClinicalTrials.gov ID
- NCT07765927
- Acronym / sponsor ID
- 202508370
- Conditions
- Breast Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jess S. GorzelitzUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
The purpose of this pilot study is to test a supervised exercise program for adults with a history of breast or gynecologic cancer to see if it is safe, helpful, and easy to take part in.
Detailed description
This pilot study will enroll up to 30 adult cancer patients to participate in a structured exercise oncology clinic to evaluate and refine clinical procedures for individualized exercise assessment and prescription. The study is designed to generate preliminary data on the feasibility, acceptability, and safety of implementing a supervised exercise program integrated into oncology care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised, Personalized Exercise Program | Experimental | Other: Supervised, Personalized Exercise ProgramThe clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Confirmed diagnosis of breast or gynecologic cancer (any stage)
- Willingness to participate in the exercise oncology program and associated research procedures Ability to provide informed consent
- Clearance to participate in exercise as determined by completion of the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and any additional clinical screening as needed
Key exclusion criteria (3 listed)
- Presence of absolute contraindications to exercise (e.g., unstable cardiovascular disease, acute illness, or other conditions that preclude safe participation in physical activity)
- Determination by a referring or treating healthcare provider that the patient is not appropriate for exercise participation at the time of screening
- Inability to complete required screening procedures, including the PAR-Q+
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 |
|---|---|---|
| Supervised, Personalized Exercise ProgramSessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety. | Other | Supervised, Personalized Exercise Program |
Primary outcome
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
Time frame: Recruitment period which will start at day 1 through two months
Recruitment rate will be reported as a proportion (percentage) each month
Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Retention rate will be reported as a proportion (percentage)
Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Summarized as mean adherence (%) and proportion meeting predefined adherence thresholds (e.g., >70%;>80%).
Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
All feasibility outcomes will be summarized using descriptive statistics (means, standard deviations, medians, ranges, and proportions with 95% confidence intervals where appropriate).
4 secondary outcomes
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Participant perceived burden (e.g., time, effort, difficulty) reported descriptively and categorized (low/moderate/high burden)
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
Time frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
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 14 Aug 2026.
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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.
Jess Gorzelitz, PhD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised, Personalized Exercise Program in people with Breast Cancer and Gynecologic Cancer, run by Jess S. Gorzelitz 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 3 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 14 Aug 2026. 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 Jess Gorzelitz, PhD, MS ((319) 467-0849, jessica-gorzelitz@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period. (time frame: Recruitment period which will start at day 1 through two months). The study lists 4 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 14 Aug 2026.