Förbättring av kognition efter cancer (I Can!)
En randomiserad studie av fysisk aktivitet för kognitiv funktion hos bröstcanceröverlevande
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
La Jolla, California, Förenta staterna, 92093
- Moores UCSD Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Aktiv komparator: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digit Test
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 182113
- 5R01CA225746 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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