Exercise Oncology Clinic Pilot Feasibility Trial
10 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-post: jessica-gorzelitz@uiowa.edu
Studieorter
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242
- Rekrytering
- University of Iowa Health Care
-
Kontakt:
- Jess Gorzelitz, PhD, MS
- Telefonnummer: (319) 467-0849
- E-post: jess-gorzelitz@uiowa.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
Tidsram: Recruitment period which will start at day 1 through two months
|
Recruitment rate will be reported as a proportion (percentage) each month
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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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).
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Pre-assessment/treatment initiation through post-intervention assessment, approximately 14 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
Tidsram: 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)
Tidsram: 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.
Tidsram: 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
|
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Participant qualitative feedback (if collected) summarized using brief thematic categorization to identify common facilitators and barriers.
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jess Gorzelitz, PhD, MS, University of Iowa
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 augusti 2026
Primärt slutförande (Beräknad)
15 december 2026
Avslutad studie (Beräknad)
15 april 2027
Studieregistreringsdatum
Först inskickad
31 juli 2026
Först inskickad som uppfyllde QC-kriterierna
10 augusti 2026
Första postat (Faktisk)
14 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202508370
Läkemedels- och apparatinformation, studiedokument
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