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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Online Nutrition Education for breast cancer?

Research shows that nutrition education programs, like the NutriCare program, are well-received by breast cancer survivors, with many participants reporting positive impacts on their diet and a significant improvement in physical function. Additionally, women with breast cancer express a strong interest in nutrition information, indicating the potential value of such educational interventions. ^{1 2 3 4 5}

Is online nutrition education safe for breast cancer patients?

Research suggests that online nutrition education is generally safe for breast cancer patients. Studies have shown that nutrition education can be beneficial, providing social and emotional support, and improving dietary intake without any reported safety concerns. ^{2 3 6 7 8}

How does online nutrition education differ from other treatments for breast cancer?

Online nutrition education for breast cancer is unique because it focuses on providing flexible, accessible learning about nutrition to improve outcomes for survivors, unlike traditional treatments that may not emphasize dietary education. This approach can be tailored to individual needs and is delivered through e-learning, making it more adaptable and convenient compared to in-person sessions. ^{1 2 6 8 9}

Research Team

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

Able to understand and willing to sign written informed electronic (e) consent in English

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Nutrition into Outpatient Oncology Care-A Pilot Trial of the NutriCare Program. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Nutritional concerns of women with breast cancer. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Web-Based Nutrition Information in Spanish for Cancer Patients and Survivors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Nutrition education of the cancer patient and family. Myths and realities. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nutrition education intervention for women with breast cancer: effect on nutritional factors and oxidative stress. [2015]

6. Scotland pubmed.ncbi.nlm.nih.gov

Translating research into practice: evaluation of an e-learning resource for health care professionals to provide nutrition advice and support for cancer survivors. [2021]

7. England 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. [2022]

8. China (Republic : 1949- ) 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nutrition Education Services Described on National Cancer Institute (NCI)-Designated Cancer Center Websites. [2020]