Nutrition Support for Cancer Survivors

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using Instacart for grocery delivery and receiving nutrition support can improve food insecurity among cancer survivors. The goal is to help participants adhere to healthy eating guidelines, potentially enhancing their overall health. Participants will receive an Instacart voucher and weekly support calls for nutrition and grocery ordering assistance. This trial suits cancer survivors not currently undergoing active treatment who struggle to access sufficient nutritious food. Participants must have internet access and experience food insecurity or belong to certain at-risk groups. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance access to nutritious food for cancer survivors.

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 prior data suggests that this nutrition support method is safe for cancer survivors?

Research has shown that good nutrition is important for cancer survivors. Eating well can help manage symptoms and improve quality of life. Studies have found that cancer patients who eat nutritious foods cope better with treatment side effects, potentially experiencing fewer issues from their cancer therapy.

The nutritional support in this study focuses on helping patients eat well without involving new drugs or experimental treatments, which often carry unknown safety concerns. Instead, it uses familiar resources like grocery delivery and nutrition advice, which are already widely used and considered safe.

In summary, the nutritional plan in this study is safe. It aims to help cancer survivors eat better using tools like Instacart and nutrition guidance. This approach is well-tolerated and has not been linked to any negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nutritional intervention for cancer survivors because it offers a holistic and personalized approach to post-treatment care. Unlike standard treatments that often focus solely on medical therapies, this intervention provides cancer survivors with practical tools like an Instacart voucher for grocery delivery and weekly nutrition navigation phone calls. This unique support system helps survivors adhere to nutrition guidelines, potentially improving their overall health and quality of life through better dietary habits.

What evidence suggests that using Instacart and nutrition navigation is effective for improving food insecurity in cancer survivors?

Research has shown that improving nutrition can help cancer patients feel better. In one study, 68% of patients improved with better nutrition. The goal is to positively change body composition, leading to better health outcomes for cancer patients. A review found that dietary changes can affect symptoms and overall health. This trial includes a supportive care arm where participants receive an Instacart grocery delivery voucher and nutrition navigation phone calls. These findings suggest that making nutritious food more accessible, along with support like grocery delivery and nutrition guidance, can help cancer survivors manage food insecurity and improve their health. ^{1 6 7 8 9}

Who Is on the Research Team?

Sorbarikor Piawah, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10407697/

nutrition as prevention for improved cancer outcomes - PMC Nutritional interventions before and during treatment can potentially influence intermediate outcomes, such as treatment-related symptoms, and distal outcomes, ...

2. academic.oup.com academic.oup.com/jnci/article/116/7/1026/7617726

Dietary interventions in cancer: a systematic review of all ... In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667268525000555

A quality improvement project for cancer patients ... The outcomes of this project were encouraging. Out of 102 patients, 68% displayed notable enhancement in nutrition (P=0.001), evidenced by MST scores below 2 ...

4. clinscinutr.org clinscinutr.org/article/view/109

Individualized nutritional management for cancer patients The main goal in performing nutritional intervention is to affect body composition positively in order to improve outcomes of the cancer ...

5. cancer.gov cancer.gov/about-cancer/treatment/side-effects/appetite-loss/nutrition-hp-pdq

Nutrition in Cancer Care (PDQ®) - NCI Nutrition in cancer care can be affected by the tumor or by treatment and result in weight loss, malnutrition, anorexia, cachexia, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2770876/

Nutrition During and After Cancer Therapy - PMC Diet and nutritional factors play a large role in influencing both the quality and quantity of life after the diagnosis of cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624003018

Review of Nutrition Guidelines and Evidence on Diet ... This study aimed to review the current nutrition guidelines for cancer survivors in the United States and evaluate the recent evidence from systematic reviews ...

8. espen.org espen.org/files/ESPEN-Guidelines/ESPEN-practical-guideline-clinical-nutrition-in-cancer.pdf

Clinical Nutrition in cancer Nutri- tional therapy in cancer patients who are malnourished or at risk of malnutrition has been shown to improve body weight and energy intake but not ...

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21719

American Cancer Society nutrition and physical activity ... The overall 5-year relative survival rate for all cancers combined is now 68%, and there are over 16.9 million survivors in the United ...