Clinical trial NCT05874297: Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer
Official title: Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Accrual rate
timeFrame: ~4 months
measure: Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics
timeFrame: ~4 months
measure: Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics
timeFrame: ~4 months
measure: Time of use of cook for your life website (adherence: total time) will be measured via Google analytics
timeFrame: ~4 months
measure: Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics
timeFrame: ~4 months
measure: User pathways of cook for your life website (adherence) will be measured via Google analytics
timeFrame: ~4 months
measure: Participant retention will be measured via participants competing surveys at all timepoints
timeFrame: ~4 months
measure: Acceptability of cook for your life website will be measured via an exit interview
timeFrame: ~4 months
Secondary outcomes:
measure: Incidence of patient-reported nutrition-related adverse events
timeFrame: ~4 months
measure: Number of participants with treatment delays and causes of delays
timeFrame: ~4 months
measure: Delivered dose of planned treatment
timeFrame: ~4 months
measure: Change in dose
timeFrame: ~4 months
measure: Change in weight
timeFrame: ~4 months
measure: Medication adherence assessed via chart abstraction
timeFrame: ~4 months
measure: Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global
timeFrame: ~4 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather Greenlee
role: PRINCIPAL_INVESTIGATOR
References: