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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

30

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Jess S. Gorzelitz

Investigators

  • 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)

August 3, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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