Exercise Oncology Clinic Pilot Feasibility Trial

NCT07765927 | Recruiting DMC

• 1 other identifier: 202508370
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  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%).

  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).

  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.

  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)

  Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks

• Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.

  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.

  Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks

Study Arms (1)

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.

Other: Supervised, Personalized Exercise Program

Interventions

Supervised, Personalized Exercise Program OTHER

Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.

Supervised, Personalized Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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+

Sponsors & Collaborators

• Jess S. Gorzelitz: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jess Gorzelitz, PhD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jess Gorzelitz, PhD, MS

CONTACT

(319) 467-0849; jessica-gorzelitz@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 14, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

US (1)