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Recruiting NCT05874297

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

No phase Interventional Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Internet-Based Intervention, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Other Best Practice
    Receive standard of care
  • Behavioral Internet-Based Intervention
    Access to enhanced Cook for your life website
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Accrual rate [Time frame: ~4 months]
  • Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics [Time frame: ~4 months]
  • Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics [Time frame: ~4 months]
  • Time of use of cook for your life website (adherence: total time) will be measured via Google analytics [Time frame: ~4 months]
  • Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics [Time frame: ~4 months]
  • User pathways of cook for your life website (adherence) will be measured via Google analytics [Time frame: ~4 months]
  • Participant retention will be measured via participants competing surveys at all timepoints [Time frame: ~4 months]
  • Acceptability of cook for your life website will be measured via an exit interview [Time frame: ~4 months]
Secondary outcome measures (7)
  • Incidence of patient-reported nutrition-related adverse events [Time frame: ~4 months]
  • Number of participants with treatment delays and causes of delays [Time frame: ~4 months]
  • Delivered dose of planned treatment [Time frame: ~4 months]
  • Change in dose [Time frame: ~4 months]
  • Change in weight [Time frame: ~4 months]
  • Medication adherence assessed via chart abstraction [Time frame: ~4 months]
  • Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global [Time frame: ~4 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT05874297 · RG1122898 · NCI-2022-10270 · 11109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗