Recruiting

Nutrition Education

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT05874297

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Internet-Based Intervention

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Study ID

NCT05874297

Start date

Jul 15, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

Best Practice

Receive standard of care

Internet-Based Intervention

Access to enhanced Cook for your life website

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Accrual rate [ Time Frame: ~4 months ]
  • Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics [ Time Frame: ~4 months ]
  • Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics [ Time Frame: ~4 months ]
  • Time of use of cook for your life website (adherence: total time) will be measured via Google analytics [ Time Frame: ~4 months ]
  • Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics [ Time Frame: ~4 months ]
  • User pathways of cook for your life website (adherence) will be measured via Google analytics [ Time Frame: ~4 months ]
  • Participant retention will be measured via participants competing surveys at all timepoints [ Time Frame: ~4 months ]
  • Acceptability of cook for your life website will be measured via an exit interview [ Time Frame: ~4 months ]

Central Contacts and Locations

Central contacts

Heather Greenlee

206.667.4502hgreenlee@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Heather Greenlee

206-667-4502hgreenlee@fredhutch.org

Principal Investigator:

Heather Greenlee

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-06.