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Online Nutrition Education for Breast Cancer (ONE Trial)
N/A
Waitlist Available
Led By Heather Greenlee
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Women must not be pregnant at time of enrollment based on self-report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~4 months
Awards & highlights
Summary
This trial tests an online nutrition education program to help breast cancer patients better manage symptoms related to chemotherapy. It could improve supportive oncology care.
Who is the study for?
This trial is for English-speaking adults with Stage I-III breast cancer, scheduled to receive specific chemotherapy regimens. Participants must have internet access and be willing to engage in study activities throughout their treatment. Pregnant women or those planning pregnancy during chemotherapy are excluded.Check my eligibility
What is being tested?
The trial examines an online nutrition education program from the Cook for Your Life website, aiming to reduce nutritional side effects of chemotherapy in breast cancer patients. It's tested alongside standard care to potentially enhance symptom management.See study design
What are the potential side effects?
While this trial focuses on educational support rather than medication, potential indirect side effects may include information overload or stress from dietary changes suggested by the online program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am not pregnant.
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My breast cancer is at an early to mid-stage (I-III).
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I can complete all study tasks, including online forms and phone calls, until chemotherapy ends.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of cook for your life website will be measured via an exit interview
Accrual rate
Participant retention will be measured via participants competing surveys at all timepoints
+5 moreSecondary outcome measures
Change in dose
Change in weight
Delivered dose of planned treatment
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (enhanced Cook for Your Life)Experimental Treatment2 Interventions
Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management.
Group II: Arm I (standard of care)Active Control2 Interventions
Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Internet-Based Intervention
2017
Completed Phase 3
~6150
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,535 Total Patients Enrolled
18 Trials studying Breast Cancer
21,498 Patients Enrolled for Breast Cancer
Heather GreenleePrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
740 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a breast cancer patient scheduled for specific chemotherapy at Fred Hutch South Lake Union.I am 18 years old or older.I am not pregnant.My breast cancer is at an early to mid-stage (I-III).I can complete all study tasks, including online forms and phone calls, until chemotherapy ends.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (enhanced Cook for Your Life)
- Group 2: Arm I (standard of care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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