Feasibility of a Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors
2026년 7월 2일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5S 2W6
- 모병
- University of Toronto - Athletic Centre
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연락하다:
- Deema Khalaf, BSc
- 전화번호: +1 (416)-946-3624
- 이메일: deema.khalaf@utoronto.ca
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연락하다:
- Linda Trinh, PhD
- 전화번호: +1 (416)-946-3624
- 이메일: linda.trinh@utoronto.ca
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수석 연구원:
- Deema Khalaf, BSc
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부수사관:
- Linda Trinh, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Enrollment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective Sedentary Behaviour
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 12월 30일
기본 완료 (추정된)
2026년 9월 1일
연구 완료 (추정된)
2026년 9월 1일
연구 등록 날짜
최초 제출
2026년 7월 2일
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 2일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Society for Endocrinology초대로 등록
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