암 후 인지 개선 (I Can!)
유방암 생존자의 인지 기능을 위한 신체 활동의 무작위 시험
This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
연구 개요
상세 설명
Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
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La Jolla, California, 미국, 92093
- Moores UCSD Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
- self-report difficulties with cognition since their cancer diagnosis
- self-report low levels of moderate to vigorous physical activity
- have a Fitbit compatible device with internet
- breast cancer was treated with chemotherapy and/or hormonal therapy
Exclusion Criteria:
- medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
- unable to commit to a 12-month study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Exercise Intervention
This arm will receive a 12-month individually tailored phone and email-based exercise program. |
This intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity |
|
활성 비교기: Health & Wellness Intervention
This arm will receive a 12-month health and wellness program. |
This intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digit Test
기간: Baseline to 6 months
|
The NIH Toolbox Oral Symbol Digit Test is a measure of processing speed, administered on an iPad by trained staff. Participants view a key pairing nine abstract symbols with the digits 1-9 and say aloud the digit that matches each symbol in a series, completing as many items as possible in 120 seconds. Higher scores indicate faster processing speed. |
Baseline to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
기간: Baseline to 12 months
|
The NIH Toolbox Oral Symbol Digit Test is a measure of processing speed, administered on an iPad by trained staff. Participants view a key pairing nine abstract symbols with the digits 1-9 and say aloud the digit that matches each symbol in a series, completing as many items as possible in 120 seconds. Higher scores indicate faster processing speed. |
Baseline to 12 months
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities
기간: Baseline to 6 months and Baseline to 12 months
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Cognitive Function - Abilities Subset, administered as a computerized adaptive test (CAT), which assesses self-perceived cognitive abilities (e.g., memory, attention, and concentration) in daily life. Raw scores are converted to T-scores, standardized to a mean of 50 and standard deviation of 10 in the U.S. general population reference sample. Higher T-scores indicate better self-reported cognitive function. |
Baseline to 6 months and Baseline to 12 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Hartman SJ, Shao LY, Zablocki RW, Natarajan L, Ahles T, Palmer BW, Sears DD, Tam RM, Mac V, Dillon L, Yan C, Parker BA. Effectiveness of an exercise intervention on cognition in breast cancer survivors: a randomized controlled trial. J Natl Cancer Inst. 2026 Sep 30:djag295. doi: 10.1093/jnci/djag295. Online ahead of print.
- Carlin D, Ott O, Sears DD, Ahles T, Desplats P, Hartman SJ. Exercise slows biological aging in breast cancer survivors: secondary analysis of a randomized trial. J Natl Cancer Inst. 2026 Sep 30:djag296. doi: 10.1093/jnci/djag296. Online ahead of print.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 182113
- 5R01CA225746 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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