Nutrition Support for Cancer Survivors

Recruiting at 1 trial location

Overseen By Bryan Le

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Planned surgery, Cancer therapy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does allow hormonal therapies for breast or prostate cancer patients.

What data supports the effectiveness of the treatment Instacart Voucher, Nutritional Intervention, Nutritional Therapy, Dietary Intervention, Nutrition Counseling, Telephone-Based Intervention, Telephone-Based Smoking Cessation Intervention, Phone-Based Smoking Cessation Support for cancer survivors?

Research shows that nutritional interventions and counseling can improve the nutritional status and quality of life for cancer patients, helping them manage treatment side effects and potentially improving survival rates. Additionally, behavioral interventions, like telephone-based support, have been effective in promoting healthier lifestyle changes, such as smoking cessation, which can further support recovery and overall health in cancer survivors. ^{1 2 3 4 5}

Is nutritional support safe for cancer survivors?

Nutritional support, including education and counseling, is generally considered safe for cancer survivors. It can help improve quality of life and manage malnutrition, but it's important to have guidance from trained professionals to ensure safety and effectiveness. ^{2 5 6 7 8}

How is the Nutritional Intervention treatment for cancer survivors different from other treatments?

Nutritional Intervention for cancer survivors focuses on providing personalized nutrition support to prevent malnutrition and improve overall health, which is different from other treatments that primarily target the cancer itself. This approach includes regular nutrition counseling and education to address individual dietary needs and manage side effects of cancer therapies, making it a supportive and adjunctive treatment rather than a direct anti-cancer therapy. ^{8 9 10 11 12}

What is the purpose of this trial?

This clinical trial studies whether the use of a grocery delivery service (Instacart) and nutrition navigation improves food insecurity in cancer survivors. The American Cancer Society recommends a normal body mass index, regular physical activity, and a healthy diet for cancer patients. Following these guidelines may help prevent deaths among cancer patients, but few cancer patients follow them. One reason for not following the guidelines could be due to the lack of consistent access to sufficient quantities of affordable, nutritious food for an active, healthy life (food insecurity). Instacart provides users access to foods that fall under the nutrition plan for cancer survivors that can be purchased and delivered to the user's home from many different grocery stores. Nutrition navigation provides support to cancer survivors via weekly check ins to help with following nutrition guidelines and assist with ordering groceries on the Instacart platform. Using a grocery delivery service, such as Instacart, and nutrition navigation may help improve food insecurity in cancer survivors.

Research Team

Sorbarikor Piawah, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for cancer survivors struggling with getting enough nutritious food consistently. Participants should be interested in improving their diet and willing to use a grocery delivery service like Instacart, along with receiving weekly nutrition guidance over the phone.

Inclusion Criteria

Able to speak/read English

Based on the United States Department of Agriculture (USDA) United States (U.S.) Household Food Security Survey, identify as experiencing food insecurity and/or belong to a population that the National Institutes of Health (NIH) has identified as being at risk for health disparities: Identify as a racial or ethnic minoritized group (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, Latino or Hispanic), Identify with a sexual or gender minoritized group, Annual household income < 200% of the federal poverty definition and/or education < bachelor's degree, Live in a rural and/or a persistent poverty area (based on zip code)

I had major surgery over 6 weeks ago and have fully recovered.

Exclusion Criteria

Contraindication to any study-related procedure or assessment

Living outside of the US or Canada during screening and/or the study period (outside the geographic areas that Instacart covers)

I am not planning any major surgery or specific cancer treatment during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a booklet on nutrition and physical activity, an Instacart grocery delivery voucher, and weekly nutrition navigation phone calls for 4 weeks.

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for adherence to nutrition guidelines and food insecurity status after the intervention.

4 weeks

Treatment Details

Interventions

• Instacart Voucher
• Nutritional Intervention
• Telephone-Based Intervention

Trial Overview The study tests if using Instacart for grocery delivery combined with telephone-based nutritional guidance can help cancer survivors eat better and overcome food insecurity. It aims to see if this support aligns with American Cancer Society dietary recommendations.

Participant Groups

Group I: Supportive Care (Instacart voucher, nutrition navigation) Experimental Treatment 3 Interventions

Participation receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Participation also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

The Eating As Treatment (EAT) program, which trains dietitians to use psychological techniques, significantly improved nutritional status in head and neck cancer patients undergoing radiation therapy, as evidenced by better scores on the Patient-Generated Subjective Global Assessment at the end of treatment.

Patients receiving the EAT intervention experienced not only improved nutrition but also a higher likelihood of being well-nourished, less weight loss, fewer treatment interruptions, lower depression scores, and a better quality of life compared to those receiving standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Britton, B., Baker, AL., Wolfenden, L., et al.[2019]

Cancer patients and survivors often face poor nutritional intake, which can lead to malnutrition, loss of lean body mass, and excessive weight loss during and after treatment, negatively impacting their clinical outcomes.

Obesity is common among cancer patients and can mask malnutrition, posing additional risks for cancer recurrence and survival; thus, effective nutritional education and targeted lifestyle interventions are crucial for improving adherence to dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. Greenlee, H., Santiago-Torres, M., McMillen, KK., et al.[2020]

Malnutrition is a critical issue for cancer patients, significantly affecting their response to treatment and overall survival, highlighting the need for early nutritional intervention.

The CANCER acronym serves as a guide for developing a comprehensive nutritional plan tailored to individual patient needs, emphasizing the importance of ongoing evaluation and adjustment of nutritional support throughout treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing nutrition for patients with cancer. Wilson, RL.[2013]

Nutrition therapy is crucial throughout the cancer treatment journey, from neoadjuvant therapy to survivorship, as it can significantly impact survival rates and quality of life for patients.

Maintaining or improving nutritional status during the neoadjuvant phase, especially when patients may be in poor condition, presents a valuable opportunity to enhance treatment outcomes and support recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term nutrition in patients candidate to neoadjuvant and adjuvant treatments. Lovey, J., Molnar, A., Banky, B.[2023]

Nutrition interventions can help cancer patients manage malnutrition caused by cancer and its treatments, improving their quality of life and providing a sense of control during a challenging time.

While definitive proof of efficacy may be lacking, these interventions are considered justified as long as they are safe and conducted with the patient's consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Intervention in Cancer. Heber, D., Li, Z.[2017]

A workshop by the National Institutes of Health highlighted the need for baseline screening for malnutrition risk in cancer patients, recommending that this screening be repeated during and after treatment to ensure proper nutritional support.

Current evidence shows that while nutritional interventions may help reduce malnutrition-related issues in cancer patients, many studies are of low quality and inconsistent, indicating a strong need for more rigorous research to determine their true effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. Hiatt, RA., Clayton, MF., Collins, KK., et al.[2023]

This report highlights the need for more research on optimal nutrition for cancer survivors, as most dietary guidelines focus on cancer prevention rather than post-treatment care.

It provides evidence-based dietary recommendations tailored to different phases of cancer survivorship and specific cancer types, along with a FAQ section to enhance communication between survivors and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. Brown, J., Byers, T., Thompson, K., et al.[2019]

A cluster-randomized clinical trial involving 468 cancer patients receiving radiotherapy showed that an evidence-based nutrition education and counseling (NEC) program significantly improved nutrition status, as indicated by lower PG-SGA scores (5.6 vs 6.9) and reduced malnutrition rates (56.0% vs 70.5%) compared to usual care.

The study demonstrates that implementing NEC in clinical settings can effectively reduce malnutrition among cancer patients undergoing treatment, highlighting its potential as a standard practice in radiotherapy units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. Zhang, Z., Zhu, Y., Zhang, L., et al.[2022]

Maintaining proper nutrition is crucial for cancer patients, as it supports their overall health and treatment effectiveness; the oncology team must understand factors affecting food acceptance to provide suitable dietary options.

Oral feeding is preferred, and nutritional supplements can help ensure adequate intake, but in cases of severe side effects like nausea or mucositis, intravenous feeding may be necessary to prevent malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral feedings in the cancer patient. Aker, SN.[2019]

Adequate nutrition significantly improves the clinical and psychological well-being of cancer patients, helping to counteract the negative effects of the disease and its treatments.

Malnutrition is not an inevitable consequence of cancer, and early assessment and intervention in nutritional status are crucial for effective treatment and support, requiring a collaborative approach among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of nutritional therapy. Shils, ME.[2019]

Clinicians have a variety of nutrition intervention strategies to support cancer patients facing malnutrition, emphasizing the need for tailored approaches based on individual assessments.

Oncology nurses play a crucial role in monitoring patients' nutritional status and implementing timely interventions, highlighting the importance of their knowledge in nutrition support throughout the cancer treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition support in cancer. Bloch, A.[2019]

A national survey of 1073 cancer survivors in Ireland revealed that 89% consider nutrition very important for their care, yet only 39% had been assessed by a registered dietitian, highlighting a significant gap in nutritional support.

Many survivors reported serious diet-related issues, such as weight loss (44%) and muscle loss (52%), and over a third had tried unproven alternative dietary strategies, indicating a need for better nutritional guidance and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national survey of oncology survivors examining nutrition attitudes, problems and behaviours, and access to dietetic care throughout the cancer journey. Sullivan, ES., Rice, N., Kingston, E., et al.[2021]

References

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

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). [2019]

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

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. [2020]

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

Optimizing nutrition for patients with cancer. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Long-term nutrition in patients candidate to neoadjuvant and adjuvant treatments. [2023]

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

Nutrition Intervention in Cancer. [2017]

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

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. [2023]

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

Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. [2022]

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

Oral feedings in the cancer patient. [2019]

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

Principles of nutritional therapy. [2019]

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

Nutrition support in cancer. [2019]

12. England pubmed.ncbi.nlm.nih.gov

A national survey of oncology survivors examining nutrition attitudes, problems and behaviours, and access to dietetic care throughout the cancer journey. [2021]