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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Receive standard of care
Access to enhanced Cook for your life website
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Accrual rate
Accrual rate to the study.
Time frame: ~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.
Time frame: ~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.
Time frame: ~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.
Time frame: ~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.
Time frame: ~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.
Time frame: ~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.
Time frame: ~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.
Time frame: ~4 months
Incidence of patient-reported nutrition-related adverse events
Patient-reported nutrition-related adverse events assessed via the chemotherapy patient reported outcome (PRO) tool.
Time frame: ~4 months
Number of participants with treatment delays and causes of delays
Treatment delays and causes of delays as assessed via chart abstraction
Time frame: ~4 months
Delivered dose of planned treatment
Assessed via chart abstraction.
Time frame: ~4 months
Change in dose
Assessed via chart abstraction.
Time frame: ~4 months
Change in weight
Weight change as assessed via chart abstraction.
Time frame: ~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.
Time frame: ~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.
Time frame: ~4 months
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