Anatomic Stage I Breast Cancer AJCC v8ONENCT05874297
Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer
A study testing Best Practice, Internet-Based Intervention and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Best Practice, Internet-Based Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Heather Greenlee, 206-667-4502, hgreenlee@fredhutch.org
Heather Greenlee
About this study
Official title: Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
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.
Read the 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.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- Best Practice, Internet-Based Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Internet-Based InterventionBehavioural
Access to enhanced Cook for your life website
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website. Receives: Other: Best Practice; Other: Questionnaire Administration |
| Arm II (enhanced Cook for Your Life) | Experimental | Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management. Receives: Behavioral: Internet-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
Accrual rate to the study.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
Secondary outcomes (7)
Incidence of patient-reported nutrition-related adverse events
Patient-reported nutrition-related adverse events assessed via the chemotherapy patient reported outcome (PRO) tool.
Measured: ~4 months
Number of participants with treatment delays and causes of delays
Treatment delays and causes of delays as assessed via chart abstraction
Measured: ~4 months
Delivered dose of planned treatment
Assessed via chart abstraction.
Measured: ~4 months
Change in dose
Assessed via chart abstraction.
Measured: ~4 months
Change in weight
Weight change as assessed via chart abstraction.
Measured: ~4 months
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.
Measured: ~4 months
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.
Measured: ~4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Greenlee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874297
- Sponsor's protocol ID
- RG1122898
- Other IDs
- NCI-2022-10270, 11109
- Acronym
- ONE
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT05874297
- Acronym / sponsor ID
- ONE / RG1122898
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website. |
| Arm II (enhanced Cook for Your Life) | Experimental | Behavioral: Internet-Based Intervention, Other: Questionnaire AdministrationPatients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (standard of care) |
| Internet-Based InterventionAccess to enhanced Cook for your life website | Behavioural | Arm II (enhanced Cook for Your Life) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (enhanced Cook for Your Life) |
Primary outcome
Accrual rate
Time frame: ~4 months
Accrual rate to the study.
Use of cook for your life website pages (adherence: visiting website) will be measured via Google analytics
Time frame: ~4 months
Google analytics will be used to identify whether participants visit the website.
Use of cook for your life website pages (adherence: webpages viewed) will be measured via Google analytics
Time frame: ~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
Time frame: ~4 months
Google analytics will be used to measure how much total time spent on the website.
Time of use of cook for your life website (adherence: time per webpage) will be measured via Google analytics
Time frame: ~4 months
Google analytics will be used to measure time spent per webpage visited.
User pathways of cook for your life website (adherence) will be measured via Google analytics
Time frame: ~4 months
Google analytics will be used to determine the order/sequence of webpages participants follow to navigate through the website.
Participant retention will be measured via participants competing surveys at all timepoints
Time frame: ~4 months
The number of participants who complete all study activities through the end of chemotherapy.
Acceptability of cook for your life website will be measured via an exit interview
Time frame: ~4 months
Participant acceptability of cook for your life website will be assessed via a short semi-structured exit interview.
7 secondary outcomes
Incidence of patient-reported nutrition-related adverse events
Time frame: ~4 months
Number of participants with treatment delays and causes of delays
Time frame: ~4 months
Delivered dose of planned treatment
Time frame: ~4 months
Change in dose
Time frame: ~4 months
Change in weight
Time frame: ~4 months
Medication adherence assessed via chart abstraction
Time frame: ~4 months
Quality of life as assessed via The Patient-Reported Outcome Measurement Information System (PROMIS)-Global
Time frame: ~4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Greenlee principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Internet-Based Intervention and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Greenlee (206.667.4502, hgreenlee@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (time frame: ~4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.