Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
Overview
- Phase
- N/A
- Intervention
- Best Practice
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Accrual rate
- Status
- Not Yet Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Investigators
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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Best Practice
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.
Intervention: Questionnaire Administration
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.
Intervention: Internet-Based Intervention
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.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Accrual rate
Time Frame: ~4 months
Accrual rate to the study.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Incidence of patient-reported nutrition-related adverse events(~4 months)
- Number of participants with treatment delays and causes of delays(~4 months)
- Change in dose(~4 months)
- Change in weight(~4 months)
- Delivered dose of planned treatment(~4 months)
- Medication adherence assessed via chart abstraction(~4 months)
- Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global(~4 months)