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NCT Number: NCT07765927

Exercise Oncology Clinic Pilot Feasibility Trial

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Jess Gorzelitz, PhD, MS

CONTACT

[email protected]

(319) 467-0849

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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)

  3. 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%).

  4. 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).

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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,

Study contacts

Contact information is provided by the study sponsor or research team.

Jess Gorzelitz, PhD, MS

CONTACT

[email protected]

(319) 467-0849

Sponsors and collaborators

Lead sponsor

Jess S. Gorzelitz

Other

Registry information

Official study title

Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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