Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

— ONE  

Official title:

Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05874297
• Other study ID #: RG1122898
• Secondary ID: NCI-2022-1027011
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Fred Hutchinson Cancer Center
• Contact: Heather Greenlee
• Phone: 206.667.4502
• Email: hgreenlee[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms

Intervention

Other:
• Best Practice
Receive standard of care

Behavioral:
• Internet-Based Intervention
Access to enhanced Cook for your life website

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	Accrual rate to the study.	~4 months
Primary	Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics	Google analytics will be used to identify whether participants visit the website.	~4 months
Primary	Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics	Google analytics will be used to identify what webpages participants view.	~4 months
Primary	Time of use of cook for your life website (adherence: total time) will be measured via Google analytics	Google analytics will be used to measure how much total time spent on the website.	~4 months
Primary	Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics	Google analytics will be used to measure time spent per webpage visited.	~4 months
Primary	User pathways of cook for your life website (adherence) will be measured via Google analytics	Google analytics will be used to determine the order/sequence of webpages participants follow to navigate through the website.	~4 months
Primary	Participant retention will be measured via participants competing surveys at all timepoints	The number of participants who complete all study activities through the end of chemotherapy.	~4 months
Primary	Acceptability of cook for your life website will be measured via an exit interview	Participant acceptability of cook for your life website will be assessed via a short semi-structured exit interview.	~4 months
Secondary	Incidence of patient-reported nutrition-related adverse events	Patient-reported nutrition-related adverse events assessed via the chemotherapy patient reported outcome (PRO) tool.	~4 months
Secondary	Number of participants with treatment delays and causes of delays	Treatment delays and causes of delays as assessed via chart abstraction	~4 months
Secondary	Delivered dose of planned treatment	Assessed via chart abstraction.	~4 months
Secondary	Change in dose	Assessed via chart abstraction.	~4 months
Secondary	Change in weight	Weight change as assessed via chart abstraction.	~4 months
Secondary	Medication adherence assessed via chart abstraction	Participant medication usage assessed via chart abstraction to note medications including anti-emetics, proton pump inhibitors, anti-depressants, and anti-anxiety medication.	~4 months
Secondary	Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global	The PROMIS Global scale contains 10 items that measure self-reported physical, mental, and social health. Each question is scored on a 1 - 5 scale with a total score range of 4 - 20. Higher scores indicate better overall health.	~4 months