Exercise Oncology Clinic Pilot Feasibility Trial
2026年8月10日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jess Gorzelitz, PhD, MS
- 電話番号：(319) 467-0849
- メール：jessica-gorzelitz@uiowa.edu
研究場所
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242
- 募集
- University of Iowa Health Care
-
コンタクト：
- Jess Gorzelitz, PhD, MS
- 電話番号：(319) 467-0849
- メール：jess-gorzelitz@uiowa.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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+
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate calculated as the number of participants enrolled divided by the number approached or referred over the study period.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant satisfaction (e.g., Likert-scale survey items) summarized as means and distributions across response categories.
時間枠：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)
時間枠：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.
時間枠：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.
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jess Gorzelitz, PhD, MS、University of Iowa
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月3日
一次修了 (推定)
2026年12月15日
研究の完了 (推定)
2027年4月15日
試験登録日
最初に提出
2026年7月31日
QC基準を満たした最初の提出物
2026年8月10日
最初の投稿 (実際)
2026年8月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月14日
QC基準を満たした最後の更新が送信されました
2026年8月10日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。