Breast Cancer, Gynecologic Cancer
Conditions
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.
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.
Interventions
OTHERSupervised, 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.
Sponsors
Jess S. Gorzelitz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period. | Recruitment period which will start at day 1 through two months | Recruitment rate will be reported as a proportion (percentage) each month |
| Retention rate defined as the proportion of enrolled participants who complete the 12-week intervention and post-intervention assessment. | Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks | Retention rate will be reported as a proportion (percentage) |
| Adherence to exercise sessions calculated as the number of completed supervised exercise sessions divided by the number of prescribed sessions. | 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%). |
| Completeness of functional testing procedures defined as the proportion of participants with complete baseline and follow-up fitness assessments. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Satisfaction survey responses summarized as means and distributions across response categories. |
| 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 | Perceived burden survey responses reported descriptively and categorized (low/moderate/high burden) |
| Willingness to participate or continue exercise programming reported as proportions (%) endorsing continued participation. | Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks | Proportion of participant endorsement of exercising or continuing exercise programming. |
| 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 | Participant qualitative feedback summarized by brief theme categorization, |
Countries
United States
Contacts
CONTACTJess Gorzelitz, PhD, MS
PRINCIPAL_INVESTIGATORJess Gorzelitz, PhD, MS
University of Iowa
Outcome results
None listed