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

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment in 1 month

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8

Treatments: Other: Questionnaire Administration; Other: Best Practice; Behavioral: Internet-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05874297

RG1122898

11109

NCI-2022-10270 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm I (standard of care)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Arm II (enhanced Cook for Your Life)

Experimental group

Description:

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

Treatment:

Behavioral: Internet-Based Intervention

Other: Questionnaire Administration