Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT04200482
The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
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Notify Me18 year and older
Female
Interventional
Phase 2
Seattle, Washington, 98109, United States
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attend 1 remote diet and physical activity session
Other names: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments
Receive eHealth communication intervention
Attend 12 remote diet and physical activity sessions in 6 months
Other names: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments
Ancillary studies
Ancillary studies
Other names: Quality of Life Assessment
Time frame: At 6 months
Accrual rate will be measured by number of participants randomized during each month of study accrual.
Time frame: At 6 months
Adherence will be measured by number of online session(s) attended per participant.
Time frame: At 6 months
Adherence will be measured by the number of responses to text messages per participant.
Time frame: At 6 months
Biospecimen collection rate will be assessed based on number of biospecimens collected.
Time frame: At 6 months
Retention will be measured by the number of completed study assessments per participants.
Time frame: At 6 months
Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.
Time frame: Baseline to 6 months
Will be assessed by 24-hour dietary recalls.
Time frame: Baseline to 6 months
Will be assessed by 7-day accelerometer data.
Time frame: Baseline to 6 months
Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.
Time frame: Baseline to 6 months
Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.
Fred Hutchinson Cancer Center
Other
Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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