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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05874297.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Approved
Contact: Heather Greenlee
Phone: 206-667-4502
PRIMARY OBJECTIVE:
I. To assess the feasibility of a trial testing an adaptive mHealth intervention to improve symptom
management during breast cancer chemotherapy as assessed by accrual, engagement, adherence, retention, and acceptability.
SECONDARY OBJECTIVES:
I. To assess the preliminary effects of the intervention on patient-reported clinical nutrition related
outcomes.
II. To assess the preliminary effects of the intervention on treatment delays, delivered doses of planned treatments, and causes of the delays and changes in doses.
III. To assess the preliminary effects of the intervention on change in weight.
IV. To assess the preliminary effects of the intervention on medication utilization.
V. To assess the preliminary effects of the intervention on healthcare utilization.
VI. To assess the preliminary effects of the intervention on quality of life.
EXPLORATORY OBJECTIVES:
I. To explore the effects of the intervention on utilization of medical resources.
II. To explore utilization patterns of the use of the general and intervention-specific webpages.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorHeather Greenlee
