Exercise Oncology Clinic Pilot Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJess S. Gorzelitz
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Supervised, Personalized Exercise Program
Other interventionSessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Supervised, Personalized Exercise ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Recruitment period which will start at day 1 through two months2
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)
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks3
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%).
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks4
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).
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeksSecondary outcomes
1
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.
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks2
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)
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks3
Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation.
Proportion of participant endorsement of exercising or continuing exercise programming.
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks4
Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
Participant qualitative feedback summarized by brief theme categorization,
Time frame
Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jess S. Gorzelitz
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov