Exercise Oncology Clinic Pilot Feasibility Trial
10. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-post: jessica-gorzelitz@uiowa.edu
Studiesteder
-
-
Iowa
-
Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Health Care
-
Ta kontakt med:
- Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-post: jess-gorzelitz@uiowa.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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+
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Supervised, Personalized Exercise Program
The clinic will conduct comprehensive patient assessments, develop personalized exercise programs, and monitor progress through fitness evaluations and wearable devices.
|
Sessions will include both resistance (strength) training and aerobic exercise, delivered under the guidance of trained personnel to ensure appropriate technique, progression, and safety.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jess Gorzelitz, PhD, MS, University of Iowa
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. august 2026
Primær fullføring (Antatt)
15. desember 2026
Studiet fullført (Antatt)
15. april 2027
Datoer for studieregistrering
Først innsendt
31. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. august 2026
Først lagt ut (Faktiske)
14. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202508370
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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