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NCT Number: NCT05874297

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

Heather Greenlee

CONTACT

[email protected]

206-667-4502

Heather Greenlee

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Internet-Based Intervention

Behavioral

Access to enhanced Cook for your life website

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Accrual rate

    Time frame: ~4 months

    Accrual rate to the study.

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

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

    Time frame: ~4 months

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

Secondary outcomes

  1. Incidence of patient-reported nutrition-related adverse events

    Time frame: ~4 months

    Patient-reported nutrition-related adverse events assessed via the chemotherapy patient reported outcome (PRO) tool.

  2. Number of participants with treatment delays and causes of delays

    Time frame: ~4 months

    Treatment delays and causes of delays as assessed via chart abstraction

  3. Delivered dose of planned treatment

    Time frame: ~4 months

    Assessed via chart abstraction.

  4. Change in dose

    Time frame: ~4 months

    Assessed via chart abstraction.

  5. Change in weight

    Time frame: ~4 months

    Weight change as assessed via chart abstraction.

  6. Medication adherence assessed via chart abstraction

    Time frame: ~4 months

    Participant medication usage assessed via chart abstraction to note medications including anti-emetics, proton pump inhibitors, anti-depressants, and anti-anxiety medication.

  7. Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global

    Time frame: ~4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Greenlee

CONTACT

[email protected]

206.667.4502

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

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

Acronym: ONE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 24, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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