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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Best Practice
* Behavioral: Internet-Based Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care)<br>Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (enhanced Cook for Your Life)<br>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<br>* Access to enhanced Cook for your life website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |