Exercise Oncology Clinic Pilot Feasibility Trial

August 10, 2026 updated by: Jess S. Gorzelitz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supervised, Personalized Exercise Program
The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices.
Other: Supervised, Personalized Exercise Program
Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
Retention rate will be reported as a proportion (percentage)
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.
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%).
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.
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).
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Satisfaction survey responses summarized as means and distributions across response categories.
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
Perceived burden survey responses reported descriptively and categorized (low/moderate/high burden)
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
Proportion of participant endorsement of exercising or continuing exercise programming.
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
Participant qualitative feedback summarized by brief theme categorization,
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jess S. Gorzelitz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jess Gorzelitz, PhD, MS, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202508370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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