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

Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Behavioral: Internet-Based Intervention

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
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Greenlee; Phone Number: 206.667.4502; Email: hgreenlee@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Heather Greenlee; Phone Number: 206-667-4502; Email: hgreenlee@fredhutch.org
      • Principal Investigator: Heather Greenlee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy
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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Internet-Based Intervention; Access to enhanced Cook for your life website

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patient-reported nutrition-related adverse events	Patient-reported nutrition-related adverse events assessed via the chemotherapy patient reported outcome (PRO) tool.	~4 months
Number of participants with treatment delays and causes of delays	Treatment delays and causes of delays as assessed via chart abstraction	~4 months
Delivered dose of planned treatment	Assessed via chart abstraction.	~4 months
Change in dose	Assessed via chart abstraction.	~4 months
Change in weight	Weight change as assessed via chart abstraction.	~4 months
Medication adherence assessed via chart abstraction	Participant medication usage assessed via chart abstraction to note medications including anti-emetics, proton pump inhibitors, anti-depressants, and anti-anxiety medication.	~4 months
Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global	The PROMIS Global scale contains 10 items that measure self-reported physical, mental, and social health. Each question is scored on a 1 - 5 scale with a total score range of 4 - 20. Higher scores indicate better overall health.	~4 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: RG1122898; 11109 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2022-10270 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No