ステージI～IIIの胃食道癌生存者の身体機能を改善するための個別に調整された、監督付き遠隔運動介入、PRECISE試験 (PRECISE)
胃食道癌生存者における身体機能改善のための個別調整・監督・遠隔実施運動介入のパイロット研究（PRECISE研究）
This clinical trial tests an individually tailored, supervised, remote exercise intervention to improve physical function for stage I-III gastroesophageal cancer survivors. Modern treatments for gastroesophageal cancer are effective at treating the cancer but are often aggressive, can be difficult for patients to tolerate, and can lead to significant debilitation and a loss of independence. Exercise is one promising intervention that could improve physical function in patients with gastroesophageal cancer after finishing systemic treatment. Home based exercise interventions in patients with cancer during and after chemotherapy can improve fatigue and function. An individually tailored, supervised, remote exercise intervention may improve physical function for stage I-III gastroesophageal cancer survivors.
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVE:
I. To determine the feasibility of the exercise intervention, as measured by the percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment.
SECONDARY OBJECTIVES:
I. To determine other measures of feasibility of the exercise intervention, including eligibility, recruitment, and achievement of exercise goals.
II. To determine the change in measures of physical function (Short Physical Performance Battery [SPPB], grip strength, Two Minute Step Test [TMST], Activities of Daily Living [ADL], and instrumental ADL) from baseline to end of study.
III. To determine the change in frailty status (Deficit Accumulation Index [DAI]) from baseline to end of study.
IV. To determine the change in measures of cognitive function (Montreal Cognitive Assessment [MOCA] and Patient Reported Outcomes Measurement Information System [PROMIS] Cognitive Function Short Form) from baseline to end of study.
V. To determine the change in anxiety (General Anxiety Disorder-7 [GAD-7]) from baseline to end of study.
VI. To determine the change in depression (Patient Health Questionnaire-8 [PHQ-8]) from baseline to end of study.
VII. To determine the change in sleep quality (Insomnia Severity Index) from baseline to end of study.
VIII. To determine the change in quality of life (Short Form [SF]-36) from baseline to end of study.
IX. To evaluate adverse events (Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events [PRO-CTCAE] and Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0) during the study intervention.
X. To identify patient perspectives on the whether or not the study intervention was worthwhile.
EXPLORATORY OBJECTIVES:
I. To determine the reliability of using remote monitoring devices to measure functional health in real-time during the study intervention.
II. To determine the change in biomarkers of aging from baseline to end of study.
OUTLINE:
Patients receive access to the Moterum application and complete remotely delivered, supervised exercise sessions, over 1 hour, 3 times per week for 8 weeks. Sessions consist of both aerobic and resistance training exercises. Patients also receive written instructions and videos of strengthening exercises. Patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 6 months.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jingran Ji, MD
- 電話番号：310-829-5471
- メール：jingranji@mednet.ucla.edu
研究場所
-
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California
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Los Angeles、California、アメリカ、90095
- 募集
- UCLA / Jonsson Comprehensive Cancer Center
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コンタクト：
- Jingran Ji, MD
- 電話番号：310-829-5471
- メール：jingranji@mednet.ucla.edu
-
主任研究者：
- Jingran Ji, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults ≥ 18 years old at the start of study treatment
- Diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric cancer. Histology can be adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma
- Treated with at least one systemic therapy (chemotherapy or immunotherapy) and within 12 months of completing curative intent gastroesophageal cancer (GEC) treatment
- Have evidence of physical function impairment, defined as a SPPB score of < 12) at baseline
- Ability to understand English and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with stage I disease who underwent endoscopic resection or surgery alone without perioperative systemic therapy
- Patients with stage IV disease or unresectable locally advanced disease taking a palliative treatment approach without a clearly defined end of treatment
- Patients currently receiving ongoing systemic therapy for GEC or another malignancy
- Patients who are unable to provide informed consent
- Any other condition or pre-existing co-morbidity that would, in the Investigator's judgment, contraindicate the participation in the study due to safety concerns with study procedures
- Currently participating in another exercise intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function
研究計画
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：Supportive care (Remote exercise intervention)
Patients receive access to the Moterum application and complete remotely delivered, supervised exercise sessions, over 1 hour, 3 times per week for 8 weeks. Sessions consist of both aerobic and resistance training exercises. Patients also receive written instructions and videos of strengthening exercises. Patients undergo blood sample collection throughout the study. |
Undergo blood sample collection
他の名前：
Ancillary studies Ancillary studies Ancillary studies Receive written instructions
他の名前：
Receive videos of strengthening exercises
他の名前：
Compete exercise sessions Receive access to Moterum application Ancillary studies
他の名前：
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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 |
|---|---|---|
|
Percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment
時間枠：At 8 weeks
|
Will use descriptive statistics to summarize the participant population, feasibility metrics, and safety data. The study will be deemed feasible if > 60% (12 or more) of the 20 enrolled participants are retained. |
At 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
介入に適格となるスクリーニング対象患者の割合
時間枠：最大16ヶ月
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最大16ヶ月
|
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介入に参加することに同意する適格患者の割合
時間枠：最大6か月
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最大6か月
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研究期間終了時までに、有酸素運動および抵抗運動の継続時間と強度の目標を達成した適格参加者の割合
時間枠：最大8週間
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最大8週間
|
|
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Change in physical function
時間枠：From baseline to 8 weeks
|
Assessed via Short Physical Performance Battery. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. |
From baseline to 8 weeks
|
|
Change in grip strength
時間枠：From baseline to 8 weeks
|
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. |
From baseline to 8 weeks
|
|
Change in physical function
時間枠：From baseline to 8 weeks
|
Assessed via the two minute step test. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The two-minute step test is administered by measuring the midpoint of the participant's patella and the top of their iliac crest and measuring how many times the participant's right knee can reach this point while marching in place for 2 minutes. A higher step count means a better outcome. |
From baseline to 8 weeks
|
|
Change in activities of daily living
時間枠：From baseline to 8 weeks
|
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The activities of daily living assessment is a calculated from the physical component score of the Short Form-36 health survey. This section consists of 10 items that assess different physical activity domains. Each item has a specific response scale which corresponds to a number. These numbers are summed and transformed into a 0-100 scale, where 0 indicates the worst health and 100 indicates the best health. |
From baseline to 8 weeks
|
|
Change in instrumental activities of daily living
時間枠：From baseline to 8 weeks
|
Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The instrumental activities of daily living assessment is a 10 items survey that assess different physical activity domains. Each item will be rated and scored based on responses denoting level of limitation (a lot, a little, not at all). The total score ranges from 0 to 100 and higher scores means a better outcome. |
From baseline to 8 weeks
|
|
Change in frailty status
時間枠：From baseline to 6 months
|
Assessed via Deficit Accumulation Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Deficit Accumulation Index (DAI) is a 50-item frailty index that is derived from the Cancer and Aging Research Group geriatric assessment. The DAI evaluates deficits in multiple geriatric assessment domains. Scores range from 0-1 with a score of 0.0 representing no detected deficits and 1.0 representing the maximum deficit. Based on the score, participants will be categorized into three categories of health status: robust, prefrail, or frail. |
From baseline to 6 months
|
|
Change in cognitive function
時間枠：From baseline to 6 months
|
Assessed via Montreal Cognitive Assessment. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Montreal Cognitive Assessment (MoCA) test is a series of questions and assessments to measure eight domains of cognitive function. The MoCA is score from 0-30 with lower scores indicating worse cognitive impairment. A score of <25 suggests some degree of cognitive impairment. |
From baseline to 6 months
|
|
Change in cognitive function
時間枠：From baseline to 6 months
|
Assessed via Patient Reported Outcomes Measurement Information System Cognitive Function Short Form. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The PROMIS Short Form v2.0 - Cognitive Function Short Form 8a provides a self-reported measure of cognitive function consisting of 8 items. Each item includes a statement related to cognitive function that the patient would rate with an attribution (very often (several times a day), often (about once a day), sometimes (two or three times), rarely (once), never) that ranges from 0-5. The items will be summed to obtain a composite score from 0-40 and higher scores indicate better cognitive function. |
From baseline to 6 months
|
|
Change in quality of life
時間枠：From baseline to 6 months
|
Assessed via 36-Item Short Form Survey. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The 36-Item Short Form Health Survey (SF-36) is a composite measure of quality of life that includes 36 items related to physical (10 items) and social functioning (2 items), pain (2 items), role limitations due to physical health (4 items) and emotional problems (3 items), energy/fatigue (4 items), emotional well-being (5 items), and health perceptions (6 items). Each item is scored on a 0 to 100 range, in which a high score represents a more favorable health state. |
From baseline to 6 months
|
|
Change in sleep quality
時間枠：From baseline to 6 months
|
Assessed via Insomnia Severity Index. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Insomnia Severity Index is a self-rated questionnaire that assesses sleep problems over a 2-week time interval. Higher scores indicate more acute symptoms of insomnia (no clinically significant insomnia [0-7], subthreshold insomnia [8-14], moderate clinical insomnia [15-21], severe clinical insomnia [22-28]). |
From baseline to 6 months
|
|
Change in anxiety
時間枠：From baseline to 6 months
|
Assessed via General Anxiety Disorder-7. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The General Anxiety Disorder-7 is a 7-item questionnaire that assesses anxiety severity over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. GAD-7 total score for the 7 items ranges from 0 to 21 with higher scores indicating more anxiety (minimal anxiety [0-4], mild anxiety [5-9], moderate anxiety [10-14], severe anxiety [15-21]). |
From baseline to 6 months
|
|
Change in depression
時間枠：From baseline to 6 months
|
Assessed via Patient Health Questionnaire-8. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. The Patient Health Questionnaire-8 is an 8-item questionnaire that assesses depression over a 2-week time interval. This is calculated by assigning scores of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day) to each response. Higher scores indicate a higher likelihood of clinical depression. |
From baseline to 6 months
|
|
Incidence of adverse events
時間枠：Up to 8 weeks
|
Assessed via National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be determined at each time point per patient as the presence (yes/no) of toxicities of grade ≥ 2. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Adverse Events (AEs) experienced will be captured as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0). After grading, each AE will be assigned an attribution by the treating clinician (unlikely, possibly, probably, or definitely related to study agent). |
Up to 8 weeks
|
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Incidence of patient reported adverse events
時間枠：Up to 8 weeks
|
Assessed via Patient Reported Outcomes version of CTCAE. Will perform exploratory statistical comparisons between baseline and end of study endpoints using t-tests and Fisher exact tests to explore the efficacy of the exercise intervention. Patient-reported Adverse Events (PRO-CTCAE) is a patient-reported outcome measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Each item is scored 0-4 with higher scores indicated more severe symptoms. No total score is calculated. |
Up to 8 weeks
|
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Patient perspectives on whether or not the study intervention was worthwhile
時間枠：At 8 weeks
|
Assessed via Was it Worth It (WIWI) questionnaire. Will use descriptive statistics to summarize the proportion of participants who answer 'yes,' 'uncertain,' and 'no' to the items in the WIWI Questionnaire and compare responses between participants with improvement in physical function and those without, bivariately and multivariately controlling for other factors. |
At 8 weeks
|
協力者と研究者
捜査官
- 主任研究者：Jingran Ji, MD、UCLA / Jonsson Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-0954
- NCI-2026-00630 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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