Exercise Oncology Clinic Pilot Feasibility Trial
10. august 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-mail: jessica-gorzelitz@uiowa.edu
Studiesteder
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Health Care
-
Kontakt:
- Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-mail: jess-gorzelitz@uiowa.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jess Gorzelitz, PhD, MS, University of Iowa
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2026
Primær færdiggørelse (Anslået)
15. december 2026
Studieafslutning (Anslået)
15. april 2027
Datoer for studieregistrering
Først indsendt
31. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202508370
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .