- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02591316
Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors
Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.
The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Texas
-
San Marcos, Texas, Forenede Stater, 78666
- Texas State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
- age-matched controls must have no previous cancer diagnosis
- Female
- no history of stroke, heart attack or transient ischemic attack
- not currently pregnant; can speak, read, and write English
- can attend all testing sessions
- not blind or legally blind; nonsmoker
- no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).
Exclusion Criteria:
- male
- < 30 or > 70 years of age
- breast cancer survivor > 60 months from last treatment or currently undergoing primary treatment
- breast cancer survivor never treated with chemotherapy and/or radiation
- previous cancer diagnosis other than breast cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Breast cancer survivor
Inclusion criteria: Female breast cancer survivors (30-70yrs of age) that have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
|
|
Control
Females (30-70yrs of age) with no previous cancer diagnosis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cognition
Tidsramme: Baseline
|
A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physical Activity
Tidsramme: Baseline
|
Physical activity will be measured by a waist-worn accelerometer
|
Baseline
|
Diet Quality
Tidsramme: Baseline
|
Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire
|
Baseline
|
Body Composition (objectively measured)
Tidsramme: Baseline
|
Body composition will be evaluated by BOD POD assessment
|
Baseline
|
Inflammatory Markers
Tidsramme: Baseline
|
A fasted blood sample will be collected for measurement of inflammatory markers
|
Baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medical History
Tidsramme: Baseline
|
Self-reported medical history
|
Baseline
|
Quality of Life
Tidsramme: Baseline
|
Series of questionnaires assessing various aspects of quality of life including physical and mental health
|
Baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Krystle E Zuniga, PhD, RD, Texas State University, San Marcos
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014T34
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