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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

ONE Trial 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.

ONE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

ONE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and ~4 months for reporting.

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 more

Secondary outcome measures

Change in dose

Change in weight

Delivered dose of planned treatment

+4 more

ONE Trial 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,218 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

Media Library

Arm II (enhanced Cook for Your Life) Clinical Trial Eligibility Overview. Trial Name: NCT05874297 — N/A

Breast Cancer Research Study Groups: Arm II (enhanced Cook for Your Life), Arm I (standard of care)

Breast Cancer Clinical Trial 2023: Arm II (enhanced Cook for Your Life) Highlights & Side Effects. Trial Name: NCT05874297 — N/A

Arm II (enhanced Cook for Your Life) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05874297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals still being accepted in this clinical research?

"Contrary to expectations, clinicaltrials.gov records indicate that this particular research project is not actively seeking participants at present, although it was initially posted on June 1st 2023 and updated as recently as May 23rd 2023. However, there are still 2,367 other medical trials presently recruiting patients for participation."

Answered by AI

What objective is this investigation aiming to achieve?

"The primary aim of this clinical trial, to be evaluated during a period of roughly 4 months, is the adherence to cook for your life website pages which will be monitored through Google analytics. Secondary goals include assessing treatment delays and causes of such delays, delivered dose of planned treatments, as well as change in dose via chart abstraction."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer

2024. "Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05874297.