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治験 NCT04832763（対象：ステージI結腸直腸癌 AJCC v8、ステージII大腸がんAJCC v8、ステージIIA大腸がんAJCC v8、ステージIIB大腸がんAJCC v8、ステージIIC大腸がんAJCC v8、ステージIII大腸癌AJCC v8、ステージIIIA大腸癌 AJCC v8、ステージIIIB大腸癌 AJCC v8、ステージIIIC大腸癌 AJCC v8、ステージ IV 大腸がん AJCC v8、ステージIVA大腸がん AJCC v8、ステージIVB大腸がん AJCC v8、ステージIVC大腸がん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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南カリフォルニア大学Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
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 NCT04832763 は 介入研究 臨床試験 で、ステージI結腸直腸癌 AJCC v8、ステージII大腸がんAJCC v8、ステージIIA大腸がんAJCC v8、ステージIIB大腸がんAJCC v8、ステージIIC大腸がんAJCC v8、ステージIII大腸癌AJCC v8、ステージIIIA大腸癌 AJCC v8、ステージIIIB大腸癌 AJCC v8、ステージIIIC大腸癌 AJCC v8、ステージ IV 大腸がん AJCC v8、ステージIVA大腸がん AJCC v8、ステージIVB大腸がん AJCC v8、ステージIVC大腸がんAJCC v8 に関するものです。現在は 実施中／登録終了 で、2019年9月27日 から開始しています。32 名の参加者 の募集が計画されています。この治験は 南カリフォルニア大学 によって主催され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月4日 です。
概要
This study investigates the medical and psychosocial consequences of colorectal cancer on adolescents and young adults. Measuring physical function in adolescents and young adults with colorectal cancer may help doctors better understand the level of physical function during cancer treatment and how to improve the management of colorectal cancer in adolescents and young adults. This study may also help design a future exercise program to decrease risk factors including high blood pressure, high blood sugar, and high cholesterol.
詳細説明
PRIMARY OBJECTIVES:
I. To prospectively characterize the symptom burden and assess the health-related quality of life of adolescents and young adults (AYAs) in active treatment for colorectal cancer in comparison to older patients to identify differences that contribute to the development of appropriately timed, age appropriate interventions.
II. To characterize the symptom burden and assess the health-related quality of life of AYAs who have completed curative therapy and are in surveillance for colorectal cancer compared to older patients to identify differences that contribute to the development of appropriately timed, age-appropriate interventions.
SECONDARY OBJECTIVE:
I. Using a prospective and cross-sectional design, characterize physical function, body composition, and biomarkers of comorbid conditions among AYAs with colorectal cancer (CRC) on active therapy and after completion of therapy in survivorship to identify targets for and timing of interventions.
EXPLORATORY OBJECTIVE:
I. To assess across Aims differences by cancer site (colon versus [vs.] rectal) by sex, and by race/ethnicity.
OUTLINE:
Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline.
公式タイトル
Colorectal Cancer in Adolescents and Young Adults: A Pilot Study of Medical and Psychosocial Issues
疾患／病気
ステージI結腸直腸癌 AJCC v8ステージII大腸がんAJCC v8ステージIIA大腸がんAJCC v8ステージIIB大腸がんAJCC v8ステージIIC大腸がんAJCC v8ステージIII大腸癌AJCC v8ステージIIIA大腸癌 AJCC v8ステージIIIB大腸癌 AJCC v8ステージIIIC大腸癌 AJCC v8ステージ IV 大腸がん AJCC v8ステージIVA大腸がん AJCC v8ステージIVB大腸がん AJCC v8ステージIVC大腸がんAJCC v8その他の研究識別子
- 3C-19-4
- NCI-2020-02581 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 3C-19-4 (その他の識別子) (USC / Norris Comprehensive Cancer Center)
- P30CA014089 (米国NIHの助成金/契約)
主目的
その他
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Physical function testing, questionnaire Patients on active treatment complete questionnaires and undergo collection of blood samples and physical function assessments at baseline, and at 3 and 6 months. Survivors in surveillance complete questionnaires and undergo collection of blood sample and physical function assessment at baseline. | 生体試料採取 Undergo collection of blood sample 医療記録レビュー Review of medical charts 身体能力検査 Undergo physical function testing 生活の質評価 Ancillary studies アンケート管理 Complete questionnaire |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Symptom Burden | Symptom burden will be assessed with computer adaptive tests (CATs) from the PROMIS measurement system. PROMIS is an NIH-sponsored system for measuring patient-reported health status, including physical, mental, and social well-being. Participants will complete the PROMIS Anxiety, Depression, Fatigue, and Pain Interference computer adaptive tests (CATs), which administer the minimum number of items necessary to accurately measure patient-reported outcomes while minimizing participant burden. | Up to 6 months |
Change in health-related quality of life (HRQoL) | HRQoL will be measured using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life Instrument, a disease-specific quality of life measure. The FACT-C includes 38 items assessing five domains of health-related quality of life: Physical, Social/Family, Emotional and Functional Well-Being, and a subscale that examines health symptoms specific to CRC patients. Participants evaluate how they have been feeling over the preceding week on a five-point Likert-type scale with a possible total score of 0 to 136, with higher scores reflecting better QoL. | Baseline up to 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Physical function - cardiorespiratory fitness | Physical function will be measured using the following in-lab test for cardiorespiratory fitness (6-minute walk test): 6-minute Walk Test (6MWT): Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes. The investigator will follow behind the participant so as not to pace the participant, and record the distance covered. Approximate time: 10 minutes. | Up to 6 months |
Physical function - power (stair climb) | Functional power will be measured using a stair climb test (Margaria Stair Climb) that has been successfully performed and correlated with lower-extremity power and mobility performance in older adults with a reliability coefficient of 0.99. Participants will be instructed to ascend a flight of 10 stairs one step at a time as quickly as possible without using a handrail. Timing will begin when one foot steps on the 3rd stair, and ends when one foot reaches the 9th stair. Time is recorded to the nearest .01 second, and an average of 3 trials is calculated. One practice trial will be given before the 3 trials.
Approximate time: 5 minutes. | Up to 6 months |
Physical function - Mobility | Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 meters from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time to complete the task, with one practice trial given. An average of time for 3 trials is calculated. Approximate time: 5 minutes | Up to 6 months |
Body composition | Body composition will be assessed via bioelectrical impedance using a validated device (InBody 570, Cerritos, CA). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight. A tape measure will be used to obtain hip circumference defined as the distance around the widest girth of the buttocks using the greater trochanter as a landmark. A tape measure will be used to obtain waist circumference defined as the distance around the midpoint between the last palpable rib and top of the iliac crest. | Up to 6 months |
Biomarker analysis - insulin | Fasting insulin levels measured in blood | Up to 6 months |
Biomarker analysis - glucose | Fasting glucose levels measured in blood | Up to 6 months |
Biomarker analysis - C-Reactive Protein | C- reactive protein levels measured in blood | Up to 6 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Diagnosis of colorectal cancer (any stage)
- Any type of prior therapy
- Age >= 18-39 years for AYA/young adult sample, age 40+ for older comparison group
- For patients on active therapy: must have been diagnosed within the past three months. For survivors: must have completed curative therapy and are 6-24 months post-diagnosis
- Speak English or Spanish
- Ability to understand and the willingness to sign a written informed consent
- Patients who are more than 3 months from diagnosis, and survivors who are more than 24 months from initial diagnosis
- Patients who have a life expectancy of less than 6 months per their medical oncologist
- Patients who are deemed too ill or unable to participate by their medical oncologist (e.g., have cognitive impairment or brain metastases)
- Patients who do not speak English or Spanish
南カリフォルニア大学225 件のアクティブな治験を探索アメリカ国立がん研究所3028 件のアクティブな治験を探索連絡先情報がありません。
2 1カ国の場所
California
Los Angeles County-USC Medical Center, Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States