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Trial Title:
Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer
NCT ID:
NCT05874297
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard of care
Arm group label:
Arm I (standard of care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Behavioral
Intervention name:
Internet-Based Intervention
Description:
Access to enhanced Cook for your life website
Arm group label:
Arm II (enhanced Cook for Your Life)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (standard of care)
Arm group label:
Arm II (enhanced Cook for Your Life)
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Heather Greenlee
Phone:
206-667-4502
Email:
hgreenlee@fredhutch.org
Investigator:
Last name:
Heather Greenlee
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874297
