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

NCT ID: NCT05874297

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer. Patients undergoing chemotherapy are at risk for complications such as diarrhea or constipation which can lead to poor nutritional intake and malabsorption of nutrients. This study is testing the effects of information delivered via the Cook for Your Life website in conjunction with standard clinical care to improve symptom management during chemotherapy treatment for breast cancer, which could serve as a new model for supportive oncology care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website.

ARM II: Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (standard of care)

Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (enhanced Cook for Your Life)

Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type BEHAVIORAL

Access to enhanced Cook for your life website

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Best Practice

Receive standard of care

Intervention Type OTHER

Internet-Based Intervention

Access to enhanced Cook for your life website

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

standard of care standard therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older.
* Stage I-III breast cancer.
* Current breast cancer patients scheduled to receive ddAC-T(+/-C), TCHP, or TCPembro-AC chemotherapy at Fred Hutch South Lake Union (can enroll prior to receipt of 2nd cycle).
* Not pregnant and no plan to become pregnant during chemotherapy treatment.
* Ability to speak and read English.
* Access to smartphone, tablet, or computer and Internet.
* Willing and able to complete all study activities through the end of chemotherapy, including completing online questionnaires and telephone assessments.
* Women must not be pregnant at time of enrollment based on self-report.
* Able to understand and willing to sign written informed electronic (e) consent in English.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Greenlee

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heather Greenlee

Role: CONTACT

206.667.4502

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Heather Greenlee

Role: primary

206-667-4502

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2022-10270

Identifier Type: REGISTRY

Identifier Source: secondary_id

11109

Identifier Type: OTHER

Identifier Source: secondary_id

RG1122898

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CAncer, NUtrition and Taste 2
NCT05027490 COMPLETED NA