Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Internet-Based Intervention (Behavioral)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Best Practice (Other)
结局指标
主要结局
Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics
时间窗: ~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
时间窗: ~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
时间窗: ~4 months
Participant acceptability of cook for your life website will be assessed via a short semi-structured exit interview.
Participant retention will be measured via participants competing surveys at all timepoints
时间窗: ~4 months
The number of participants who complete all study activities through the end of chemotherapy.
Accrual rate
时间窗: ~4 months
Accrual rate to the study.
Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics
时间窗: ~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
时间窗: ~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
时间窗: ~4 months
Google analytics will be used to determine the order/sequence of webpages participants follow to navigate through the website.
次要结局
- Change in dose(~4 months)
- Delivered dose of planned treatment(~4 months)
- Incidence of patient-reported nutrition-related adverse events(~4 months)
- Number of participants with treatment delays and causes of delays(~4 months)
- Change in weight(~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)