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NCT05874297 | NOT YET RECRUITING | Anatomic Stage I Breast Cancer AJCC v8

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

Fred Hutchinson Cancer Center

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.

Condition or disease

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer Ajc V8

Anatomic Stage III Breast Cancer AJCC v8

Intervention/treatment

Best Practice

Internet-Based Intervention

Questionnaire Administration

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer

Location Details

NCT05874297

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109