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

NCT05874297 | Not Yet Recruiting

• 3 other identifiers: RG1122898NCI-2022-1027011109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Accrual rate

  Accrual rate to the study.

  ~4 months

• Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics

  Google analytics will be used to identify whether participants visit the website.

  ~4 months

• Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics

  Google analytics will be used to identify what webpages participants view.

  ~4 months

• Time of use of cook for your life website (adherence: total time) will be measured via Google analytics

  Google analytics will be used to measure how much total time spent on the website.

  ~4 months

• Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics

  Google analytics will be used to measure time spent per webpage visited.

  ~4 months

• User pathways of cook for your life website (adherence) will be measured via Google analytics

  Google analytics will be used to determine the order/sequence of webpages participants follow to navigate through the website.

  ~4 months

• Participant retention will be measured via participants competing surveys at all timepoints

  The number of participants who complete all study activities through the end of chemotherapy.

  ~4 months

• Acceptability of cook for your life website will be measured via an exit interview

  Participant acceptability of cook for your life website will be assessed via a short semi-structured exit interview.

  ~4 months

Secondary Outcomes (7)

• Incidence of patient-reported nutrition-related adverse events

  ~4 months

• Number of participants with treatment delays and causes of delays

  ~4 months

• Delivered dose of planned treatment

  ~4 months

• Change in dose

  ~4 months

• Change in weight

  ~4 months

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Questionnaire Administration

Arm II (enhanced Cook for Your Life)

EXPERIMENTAL

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

Behavioral: Internet-Based Intervention; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (standard of care)

Internet-Based Intervention BEHAVIORAL

Access to enhanced Cook for your life website

Arm II (enhanced Cook for Your Life)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard of care); Arm II (enhanced Cook for Your Life)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Heather Greenlee

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Greenlee

CONTACT

206.667.4502; hgreenlee@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: May 24, 2023
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)