Online Nutrition Education for Breast Cancer

(ONE Trial)

Overseen By Heather Greenlee

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Must be taking: Chemotherapy

Disqualifiers: Pregnancy, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online nutrition education program designed to help breast cancer patients manage chemotherapy side effects. It aims to reduce issues like diarrhea and constipation, which can impact nutrient absorption. Participants will receive either standard care or enhanced nutritional guidance from the "Cook for Your Life" website to determine if it improves symptom management. This trial suits individuals with Stage I-III breast cancer who are currently undergoing specific chemotherapy treatments and have internet access. As an unphased trial, it provides a unique opportunity to explore innovative nutritional strategies that could enhance quality of life during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition education during chemotherapy, so it's best to discuss your medications with your doctor.

What prior data suggests that this online nutrition education program is safe for breast cancer patients undergoing chemotherapy?

Research has shown that online nutrition programs, such as Cook for Your Life, are generally safe for breast cancer patients. These programs help improve diet and physical activity. Studies have found that participants handle them well. A survey of breast cancer survivors found that 75% used the internet to learn about managing their health, indicating that online tools are popular and easy to use.

The Cook for Your Life website has helped patients manage symptoms from cancer treatment, with no reports of harmful effects.

Overall, online nutrition education appears to be a safe way to support breast cancer patients during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of online nutrition education to enhance the care of breast cancer patients. Unlike standard care, which includes symptom monitoring and nurse visits, this approach offers patients access to an enhanced version of Cook for Your Life, focusing on symptom management through nutrition. This method could empower patients with practical dietary strategies to improve their quality of life, potentially making symptom management more accessible and engaging.

What evidence suggests that this online nutrition education is effective for managing chemotherapy side effects in breast cancer patients?

Research has shown that online nutrition education can help manage chemotherapy side effects in breast cancer patients. In this trial, participants in Arm I will receive standard care, including access to the current Cook for Your Life website. Arm II participants will receive enhanced Cook for Your Life information on symptom management. One study found virtual nutrition workshops effective, with patients reporting high satisfaction. Another study demonstrated that using the Cook for Your Life website could help patients make dietary changes and improve their nutrition during cancer treatment. These programs aim to reduce common issues like diarrhea and constipation during chemotherapy. Overall, early findings suggest that online nutrition education can be a helpful tool in supportive cancer care. ^{1 2 3 4 5}

Who Is on the Research Team?

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with Stage I-III breast cancer, scheduled to receive specific chemotherapy regimens. Participants must have internet access and be willing to engage in study activities throughout their treatment. Pregnant women or those planning pregnancy during chemotherapy are excluded.

Inclusion Criteria

I am a breast cancer patient scheduled for specific chemotherapy at Fred Hutch South Lake Union.

Ability to speak and read English

Not pregnant and no plan to become pregnant during chemotherapy treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive chemotherapy treatment along with access to the Cook for Your Life website for symptom management

16 weeks

Scheduled nurse visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Online Nutrition Education

Trial Overview

The trial examines an online nutrition education program from the Cook for Your Life website, aiming to reduce nutritional side effects of chemotherapy in breast cancer patients. It's tested alongside standard care to potentially enhance symptom management.

How Is the Trial Designed?

Group I: Arm II (enhanced Cook for Your Life) Experimental Treatment 2 Interventions

Patients receive standard of care as in Arm I and access to enhanced Cook for Your Life information on symptom management.

Group II: Arm I (standard of care) Active Control 2 Interventions

Patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current Cook for Your Life website.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Published Research Related to This Trial

In a study involving 444 high-risk oncology patients, nutrition education significantly improved dietary intake, particularly in protein and total energy consumption.

The findings suggest that providing nutritional education is an effective strategy for enhancing nutrient intake in oncology patients, which is crucial for their overall health and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Malnutrition Universal Screening Tool (MUST) and a nutrition education program for high risk cancer patients: strategies to improve dietary intake in cancer patients. Chao, PC., Chuang, HJ., Tsao, LY., et al.[2022]

The NutriCare nutrition education program was successfully integrated into outpatient oncology care for 20 breast cancer survivors, with a high completion rate of 90% and positive feedback from participants regarding its feasibility and impact on their diet.

Participants showed a significant improvement in physical function after six weeks, indicating that nutrition education can have beneficial effects on health outcomes for cancer survivors, although no significant changes in overall quality of life or dietary quality were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Nutrition into Outpatient Oncology Care-A Pilot Trial of the NutriCare Program. Keaver, L., Yiannakou, I., Zhang, FF.[2021]

A pilot study involving 59 breast cancer survivors showed that nutrition education workshops were well-received and feasible, with high follow-up rates of 89% in the control group and 77% in the intervention group.

While the workshops did not significantly improve nutrition literacy scores at the 3-month follow-up, participants valued the social support and expressed a desire for more tailored dietary information, indicating potential for future interventions to enhance dietary knowledge among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial. Parekh, N., Jiang, J., Buchan, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11272921/

Cook and Move for Your Life, an eHealth intervention ...

We tested the feasibility and preliminary efficacy of an online diet and physical activity program for women with early-stage breast cancer

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S295024702400118X

Virtual nutrition education in patients with breast cancer

In this study we demonstrate the effectiveness of a disease-specific nutrition and education virtual group workshop. Patient-reported outcomes were high ...

3.

withpower.com

withpower.com/trial/phase-breast-neoplasms-5-2023-c477d

Online Nutrition Education for Breast Cancer (ONE Trial)

This trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9496813/

Characteristics of Users of the Cook for Your Life Website, ...

For cancer survivors, eating a nutritious diet may lower the risk of cancer recurrence and the development of other comorbid diseases, and may ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01414062

Cook for Your Life!: Implementing Dietary Change Among ...

The primary objectives of this study are to determine the effect of the dietary intervention (Cocinar para su salud! Program) vs. control (standard written ...