Feasibility of a Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors
2026年7月2日 更新者：Linda Trinh、University of Toronto
A Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors: A Feasibility Study
Cancer and its treatments are associated with long-term side effects including lowered physical strength and quality of life. Decreasing sedentary behaviour improves health outcomes in cancer survivors. Habit-based programs aimed at lowering sedentary behaviour have been successful in decreasing sedentary behaviour in other populations. However, limited clinical trials aimed at lowering sedentary behaviour have recruited cancer survivors, and none are exclusively based on Habit Theory.
The primary goal of this clinical trial is to test the feasibility of an 8-week, habit-based program to lower sedentary behaviour in cancer survivors. Sedentary behaviour refers to low-energy activities performed during waking hours in a seated, reclined or laid down position. Secondarily, this clinical trial aims to examine changes in sedentary behaviour, physical strength, habit, and quality of life.
Enrolled participants will be assigned to a sedentary behaviour or active control group. The sedentary behaviour group will receive 8 weekly sheets consisting of tips recommending to lower sedentary behaviour. Tips will be individualized to participants' lifestyles, and will consider their cancer-specific and other physical limitations. Participants in the sedentary behaviour group will also meet with the researcher once a week for a check-in session for more individualized tips and progressions. The active control group will receive the Canadian 24-hour Movement Guidelines, and a handout highlighting the benefits of lowering sedentary behaviour. Both groups will be provided with wearable activity monitors (Fitbits).
研究概览
详细说明
Cancer and its treatments are associated with late and long-term side effects such as reduced quality of life (QoL) and physical function.
Reducing sedentary behaviour (SED), any waking behaviour characterized by a low-energy expenditure performed while seated, reclined or lying down, has been shown to improve health outcomes in cancer survivors.
Habit is a cognitive process in which a cue triggers a specific behaviour, learned through repetition of the behaviour every time the cue is encountered.
By prompting sedentary breaks through everyday cues, SED may decrease in cancer survivors that may be sustained long-term.
Current habit-based sedentary behaviour interventions in other populations are limited as they have only used self-report measures, did not recruit control groups, and/or were not exclusively grounded in Habit Theory.
Additionally, remotely-delivered interventions may be an effective option to decrease sedentary behaviour in cancer survivors, while expanding reach and improving accessibility by overcoming barriers to participation in traditional in-person programs.
To address the current gaps in the literature, research is needed to assess the feasibility of a remotely-delivered SED program for physical function and quality of life in cancer survivors.
Therefore, the primary objective of this study is to examine the feasibility (adherence, safety, attrition, and participant satisfaction) of an 8-week, remotely-delivered, habit-based intervention to reduce SED in cancer survivors compared to an active control group (movement guidelines and sedentary behaviour handout).
Feasibility indicators are: (1) check-in session adherence rate ≥70%, (2) tip adherence ≥70% (based on goal of following 2-4 tips per day), attrition rate < 30%, and no intervention-related adverse events.
Secondary objectives include examining changes in (1) physical function, (2) general health-related and cancer-specific QoL, (3) habit, and (4) objective and device-based sedentary behaviour of cancer survivors.
The trial findings may be used to inform larger randomized controlled trials to reduce SED in cancer survivors, and may be a cost-effective and accessible option for cancer survivors to optimize their health.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5S 2W6
- 招聘中
- University of Toronto - Athletic Centre
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接触：
- Deema Khalaf, BSc
- 电话号码：+1 (416)-946-3624
- 邮箱：deema.khalaf@utoronto.ca
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接触：
- Linda Trinh, PhD
- 电话号码：+1 (416)-946-3624
- 邮箱：linda.trinh@utoronto.ca
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首席研究员：
- Deema Khalaf, BSc
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副研究员：
- Linda Trinh, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 18 years of age or older
- have been diagnosed with localized or asymptomatic metastatic cancer of any type
- completed primary cancer treatment
- self-report being sedentary for more than or equal to 8 hours per day
- access to the internet and a device with a webcam
- able to complete the study in English
Exclusion Criteria:
- presence of other primary or recurrent invasive cancer
- having experienced a fall in the last 12 months
- not residing in Canada
- participating in other behaviour change interventions
- using a gait aid device
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Sedentary Behaviour Intervention Group
The sedentary behaviour intervention will consist of weekly tick-sheets, one weekly check-in session, and a Fitbit for physical inactivity reminders over 8 weeks.
The weekly tick-sheets will consist of tips recommending to lower sedentary behaviour by enacting actions in the presence of cues.
Progressions, illustrations and steps to perform these actions will be provided as an attachment with the tick-sheets.
An example of a tip is "During TV/online video ad breaks or when you finish watching one episode of a show or online video, climb up and down a staircase to reduce cancer-related fatigue associated with prolonged sitting".
Tips will be individualized to participants' lifestyles, and will consider their cancer-specific and other physical limitations.
Participants in the sedentary behaviour group will also meet with the researcher once a week for a check-in session for more individualized tips and progressions.
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The sedentary behaviour intervention will consist of weekly tick-sheets, one weekly check-in session, and a Fitbit for physical inactivity reminders over 8 weeks.
The weekly tick-sheets will consist of tips recommending to lower sedentary behaviour by enacting actions in the presence of cues.
Progressions, illustrations and steps to perform these actions will be provided as an attachment with the tick-sheets.
An example of a tip is "During TV/online video ad breaks or when you finish watching one episode of a show or online video, climb up and down a staircase to reduce cancer-related fatigue associated with prolonged sitting".
Tips will be individualized to participants' lifestyles, and will consider their cancer-specific and other physical limitations.
Participants in the sedentary behaviour group will also meet with the researcher once a week for a check-in session for more individualized tips and progressions.
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有源比较器：Active Control Group
The active control group will receive the Canadian 24-hour Movement Guidelines, and a handout highlighting the benefits of reducing sedentary behaviour.
They will also receive Fitbits, with the hourly inactivity reminders turned off.
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The active control group will receive the Canadian 24-hour Movement Guidelines, and a handout highlighting the benefits of reducing sedentary behaviour.
They will also receive Fitbits, with the hourly inactivity reminders turned off.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Enrollment
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Participant enrollment rate will be a measure of feasibility.
Enrollment will be calculated by measuring the number of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Adherence
大体时间：From baseline (pre-intervention) to post-intervention (8 weeks).
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Adherence is another measure of feasibility.
Two types of adherence will be measured: check-in session adherence and tip adherence.
Check-in session adherence will be calculated by assessing the number of check-in sessions attended divided by the total number of check-in sessions that took place (i.e. 8 sessions).
Tip adherence will be calculated by the number of days that the daily tip goal of 2-4 tips was met, divided by 56 (7 days per week for 8 weeks).
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From baseline (pre-intervention) to post-intervention (8 weeks).
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Attrition
大体时间：Assessed from baseline (pre-intervention) to post-intervention (8 weeks).
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Attrition will be a measure of feasibility.
Attrition will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who were randomized.
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Assessed from baseline (pre-intervention) to post-intervention (8 weeks).
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Adverse Events
大体时间：From baseline (pre-intervention) to post-intervention (8 weeks).
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Adverse events will be a measure of feasibility.
This will be assessed as an unexpected and severe medical problem or injury (e.g., cardiac-related events, musculoskeletal injury or pain, falls) that occurs due to the intervention.
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From baseline (pre-intervention) to post-intervention (8 weeks).
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Participant Satisfaction
大体时间：Post-intervention (8 weeks).
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A participant satisfaction survey will be administered following the 8-week intervention to assess the acceptability of the intervention by using researcher-generated statements (e.g., "I found the sedentary behaviour reduction intervention rewarding").
The survey will assess the burden of the program and the participant's feedback regarding the sedentary behaviour intervention and overall study experience.
Likert scales ranging from 1 (not at all) to 5 (very much) will be used.
The active control group will complete a satisfaction survey which will include statements relevant to the active control arm.
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Post-intervention (8 weeks).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective Sedentary Behaviour
大体时间：Change from baseline (pre-intervention) to post-intervention (8 weeks).
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Objective sedentary behaviour will be measured using inclinometers (i.e. the ActivPAL) pre- and post-intervention.
The inclinometer records the amount of time spent lying, sitting, standing, in upright position, cycling, in seated transport, total sedentary time, and sit-to-stand transitions.
Participants will be mailed the inclinometers and will be provided instructions through videoconferencing.
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Change from baseline (pre-intervention) to post-intervention (8 weeks).
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Self-Reported Sedentary Behaviour
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Self-reported sedentary behaviour will be measured using the AusDiab3 Sedentary Behaviour Questionnaire.
This questionnaire measures the amount of time, in minutes and hours, spent seated, reclined or laying down while working, using transport, watching TV, as well as playing computer, internet, and electronic games, in the past week on weekdays and weekends.
The choices for this questionnaire are none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Habit
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Habit will be assessed using the brief Self-Report Behavioural Automaticity Index.
This is a 4-item measure that assesses the automaticity of specific behaviours (i.e.
actions in the tick-sheets to reduce sedentary behaviour).
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Physical Function
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Physical function will be measured at baseline and follow-up using the remotely-delivered 30-second sit-to-stand and 6-minute walk tests.
The purpose of the 30-second sit-to-stand test is to measure participants' lower body strength and endurance by measuring the number of full chair stands with arms folded at the chest completed in 30-seconds.
The 6-minute walk test assesses functional walking capacity by the distance walked in 6 minutes without running or jogging.
A qualified exercise professional will administer these tests.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Cancer-Specific Quality of Life
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Cancer-specific quality of life will be measured using the FACT-G.
This is a 27-item questionnaire that assesses four domains of health-related quality of life in the past 7 days: physical, social, emotional, and functional well-being .
Participants will be asked to rate each statement on a 5-point Likert scale (0= "not at all", 4= "very much") based on how much they relate to the statement.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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General-Health-Related Quality of Life
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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General health-related quality of life will be measured using the Short Form-12 questionnaire.
This questionnaire consists of 12 items that measure 8 physical and mental health-related domains: general health, physical functioning, role physical, body pain, vitality, social functioning, role emotional, and mental health.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Self-Reported Exercise
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Self-reported exercise will be measured using the modified Godin Leisure-Time Exercise Questionnaire.
Participants will report the number of times per week and minutes per session that they engage in light, moderate, and vigorous leisure-time exercise, and resistance exercise.
Total weekly minutes of moderate-to-vigorous physical activity will be calculated as the sum of the number of moderate exercise minutes per week, plus twice the number of vigorous exercise minutes per week.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Clinical Demographics
大体时间：Baseline (pre-intervention)
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Clinical variables include: cancer type, date of diagnosis, cancer stage, cancer spread, cancer stage, cancer treatment(s) received, current treatment status, previous recurrence, other cancer diagnoses, general health status, comorbidities, smoking history, and alcohol consumption history.
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Baseline (pre-intervention)
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Demographic Variables
大体时间：Baseline (pre-intervention)
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Demographic variables collected will include age (in years), sex (options are male, female, other, and prefer not to say), gender (options are agender, bigender/multigender, gender fluid, genderqueer, man, nonbinary, transgender, two-spirit, woman, other, and prefer not to say), marital status (options are single, married, common-law, separated, widowed, and divorced), highest level of education (options are some high school, completed high school, some university/college, completed university/college, some graduate school, and completed graduate school), current employment status (options are disability, retired, part-time, homemaker, full-time, and unemployed), ethnicity (options are Black, East Asian, Middle Eastern, Arab or West Asian, Latin American, South Asian, Southeast Asian, White, and other in which they would be asked to specify) as well as height (in feet and inches) and weight (in pounds) to calculate body mass index.
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Baseline (pre-intervention)
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Fatigue
大体时间：Change from baseline (pre- intervention) to post-intervention (8 weeks).
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Fatigue will be assessed at baseline and follow-up using the Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue).
The FACIT-Fatigue is a 13-item measure which assesses self-reported fatigue and its effect on daily activities and function.
Participants will be asked to rate 13 items related to their fatigue in the previous 7 days on a 5-point Likert scale (0="not at all" or "never" and 4= "very much" or "several times/day) in which higher scores indicate higher quality of life.
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Change from baseline (pre- intervention) to post-intervention (8 weeks).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tremblay MS, Aubert S, Barnes JD, Saunders TJ, Carson V, Latimer-Cheung AE, Chastin SFM, Altenburg TM, Chinapaw MJM; SBRN Terminology Consensus Project Participants. Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017 Jun 10;14(1):75. doi: 10.1186/s12966-017-0525-8.
- Park C, Larsen B, Mogos M, Muchira J, Dietrich M, LaNoue M, Jean J, Norfleet J, Doyle A, Ahn S, Mulvaney S. A multiple technology-based and individually-tailored Sit Less program for people with cardiovascular disease: A randomized controlled trial study protocol. PLoS One. 2024 May 9;19(5):e0302582. doi: 10.1371/journal.pone.0302582. eCollection 2024.
- Tam RM, Zablocki RW, Liu C, Narayan HK, Natarajan L, LaCroix AZ, Dillon L, Sakoulas E, Hartman SJ. Feasibility of a Health Coach Intervention to Reduce Sitting Time and Improve Physical Functioning Among Breast Cancer Survivors: Pilot Intervention Study. JMIR Cancer. 2023 Dec 19;9:e49934. doi: 10.2196/49934.
- Gardner, B., Rebar, A. L., de Wit, S., & Lally, P. (2024). What is habit and how can it be used to change real-world behaviour? Narrowing the theory-reality gap. Social and Personality Psychology Compass, 18(6), e12975. https://doi.org/10.1111/spc3.12975
- White I, Smith L, Aggio D, Shankar S, Begum S, Matei R, Fox KR, Hamer M, Iliffe S, Jefferis BJ, Tyler N, Gardner B. On Your Feet to Earn Your Seat: pilot RCT of a theory-based sedentary behaviour reduction intervention for older adults. Pilot Feasibility Stud. 2017 May 8;3:23. doi: 10.1186/s40814-017-0139-6. eCollection 2017.
- Matei R, Thune-Boyle I, Hamer M, Iliffe S, Fox KR, Jefferis BJ, Gardner B. Acceptability of a theory-based sedentary behaviour reduction intervention for older adults ('On Your Feet to Earn Your Seat'). BMC Public Health. 2015 Jul 2;15:606. doi: 10.1186/s12889-015-1921-0.
- Sardinha LB, Santos DA, Silva AM, Baptista F, Owen N. Breaking-up sedentary time is associated with physical function in older adults. J Gerontol A Biol Sci Med Sci. 2015 Jan;70(1):119-24. doi: 10.1093/gerona/glu193. Epub 2014 Oct 16.
- Gaskin CJ, Craike M, Mohebbi M, Salmon J, Courneya KS, Broadbent S, Livingston PM. Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors. Cancer Causes Control. 2016 Sep;27(9):1093-103. doi: 10.1007/s10552-016-0787-5. Epub 2016 Jul 28.
- Gotay CC, Muraoka MY. Quality of life in long-term survivors of adult-onset cancers. J Natl Cancer Inst. 1998 May 6;90(9):656-67. doi: 10.1093/jnci/90.9.656.
- Grusdat NP, Stauber A, Tolkmitt M, Schnabel J, Schubotz B, Wright PR, Schulz H. Routine cancer treatments and their impact on physical function, symptoms of cancer-related fatigue, anxiety, and depression. Support Care Cancer. 2022 May;30(5):3733-3744. doi: 10.1007/s00520-021-06787-5. Epub 2022 Jan 11.
- Muhandiramge J, Orchard SG, Warner ET, van Londen GJ, Zalcberg JR. Functional Decline in the Cancer Patient: A Review. Cancers (Basel). 2022 Mar 8;14(6):1368. doi: 10.3390/cancers14061368.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月30日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月2日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.