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治験 NCT06213571（対象：FIGOグレード1子宮内膜類内膜腺癌、FIGOグレード2子宮内膜類内膜腺癌、ステージIA子宮体癌 AJCC v8、ステージIB子宮体がん AJCC v8）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メイヨー・クリニックRemote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06213571 は 介入研究 臨床試験 で、FIGOグレード1子宮内膜類内膜腺癌、FIGOグレード2子宮内膜類内膜腺癌、ステージIA子宮体癌 AJCC v8、ステージIB子宮体がん AJCC v8 に関するものです。現在は 実施中／登録終了 で、2024年3月22日 から開始しています。80 名の参加者 の募集が計画されています。この治験は メイヨー・クリニック によって主催され、2026年3月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月6日 です。
概要
This clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (EC) survivorship for patients with decreased cancer survivorship access. Cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. Rural areas in the Midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. Remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. In addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. Information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact EC survivorship for patients with decreased cancer survivorship access.
詳細説明
PRIMARY OBJECTIVES:
I. To develop and tailor a fully remote home-based exercise intervention for EC patients.
II. To test the recruitment and retention and acceptability of a fully remote home-based telehealth exercise intervention in older adult patients that live in rural America and are survivors of early stage, low risk endometrial cancer.
III. To measure the effectiveness of exercise intervention on quality of life in endometrial cancer patients, specifically in the realm of physical functioning.
OUTLINE:
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
After completion of study intervention, patients are followed up at 6 months.
公式タイトル
RISE: Remote Intervention for Strength Training in Endometrial Cancer
疾患／病気
FIGOグレード1子宮内膜類内膜腺癌FIGOグレード2子宮内膜類内膜腺癌ステージIA子宮体癌 AJCC v8ステージIB子宮体がん AJCC v8その他の研究識別子
- 23-008883
- NCI-2023-11096 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 23-008883 (その他の識別子) (Mayo Clinic in Rochester)
主目的
支持療法
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Supportive Care (home-based exercise program) Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study. | 運動カウンセリング Participate in exercise coaching sessions 運動介入 Participate in home-based exercise program 健康促進と教育 Receive resistance band and exercise booklets インタビュー Ancillary studies 身体能力検査 Ancillary studies アンケート管理 Ancillary studies 遠隔医療 Participate in sessions remotely |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Retention of participants | Assessed by the number of patients who complete 75% or more of the twice weekly exercise program. | Up to 2 years |
Satisfaction with program - self-reported | Assessed by a simple participant satisfaction survey after completion of the 10-week exercise intervention. Qualitative interviews will be performed at the completion of the program regardless of level of participation to assess facilitators, barriers, and motivators to participation. | 10 weeks |
Feasibility of intervention | Technological questions and problems that arise during the exercise intervention will be recorded to assess the ability to fully perform telehealth exercise interventions in a rural cancer population | Up to 2 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in physical function | Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b assessment, a 6-item questionnaire answered on a scale from 5 (Without any difficulty or Not at all) to 0 (Unable to do or Cannot do). | Baseline; 10 weeks (end of exercise intervention); 6 months after completion of intervention |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
女性
- Age 50+
- Stage IA-IB endometrial cancer
- Grade 1-2 disease
- No recurrence documented
- Internet access
- Access to a remote device with a camera such as a computer, smartphone or tablet
- > 1 year but less than 5 years from surgery
- Primary residence in rural-urban commuting area (RUCA) (rural-urban commuting area) codes 4.0 through 10.0 or of American Indian, Alaskan Native, Black or Hispanic background
- Paraplegia/hemiplegia
- No English speaking
メイヨー・クリニック868 件のアクティブな治験を探索連絡先情報がありません。
1 1カ国の場所
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States