Hematopoietic and Lymphatic System NeoplasmNCT06602999
Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
A study testing Nutritional Intervention, Instacart Voucher and Telephone-Based Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Nutritional Intervention, Instacart Voucher and Telephone-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis of a malignant cancer (except non-melanoma skin cancer).
- Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy, targeted therapies) during the study period. Hormonal therapies are allowed for patients with breast or prostate cancer
- At least 6 weeks since a major surgery and fully recovered.
- Have access to the internet and able to send and receive text messages.
- Able to speak/read English.
Show all 11Show fewer
- 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, as defined by the NIH (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).
Who cannot join
- Contraindication to any study-related procedure or assessment.
- Planned major surgery or cancer-directed therapy during the study period.
- Living outside of the US or Canada during screening and/or the study period (outside the geographic areas that Instacart covers).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the intervention's feasibility and acceptability.
SECONDARY OBJECTIVES:
- To estimate the effect of the intervention on adherence to American Cancer society nutrition guidelines.
II. To estimate the effect of the intervention on self-reported food insecurity.
III. To evaluate the feasibility of patient navigation calls. IV. To evaluate the feasibility of Instacart vouchers.
EXPLORATORY OBJECTIVE:
- To evaluate the feasibility of the intervention through an end-of-study semi-structured interview.
OUTLINE:
Patients receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Patients also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart once a week (QW) for 4 weeks.
After completion of study intervention, patients are followed up at 28 days.
- Being tested
- Nutritional Intervention, Instacart Voucher, Telephone-Based Intervention
- Keywords
- Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionOther
Receive a booklet on nutrition and physical activity for cancer survivors
Instacart VoucherOther
Also called Nutritional Intervention
Receive Instacart grocery delivery voucher
Telephone-Based InterventionBehavioural
Receive nutrition navigation phone calls
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (Instacart voucher, nutrition navigation) | Experimental | Participants receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Participants also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks. Receives: Other: Nutritional Intervention; Other: Instacart Voucher; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Score on the Feasibility of Intervention Measure (FIM) Survey
The FIM is a four-item measure of implementation that assesses participants perceived feasibility of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher values representing a greater feasibility. The intervention will be determined feasible if the overall median score is >= 4. The median and full range of the FIM scores will be reported.
Measured: At 4 week assessment, 1 day
Median Score on the Acceptability of Intervention Measure (AIM) Survey
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a greater acceptability of the intervention. The intervention will be determined acceptable if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
Measured: At 4 week assessment, 1 day
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a higher agreement with the appropriateness of the intervention. The intervention will be determined appropriate if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
Measured: At 4 week assessment, 1 day
Secondary outcomes (8)
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Measured: Up to 4 weeks
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Measured: Up to 4 weeks
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Measured: Up to 4 weeks
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Measured: Up to 4 weeks
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range will be used to describe the change of overall adherence over time.
Measured: Up to 4 weeks
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
The United States Department of Agriculture Food Insecurity Questionnaire consists of 6 items that address various aspect of food security. Responses of "often" or "sometimes" and "yes" are coded as affirmative. Responses of "almost every month" and "some months but not every month" are coded as affirmative. The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1 = High or marginal food security (raw score=1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score of 0 on the six-item scale), Raw scores of 2-4=Low food security, Raw scores 5-6=Very low food security. The mean change in raw score over time will be reported along with the standard deviation.
Measured: Up to 4 weeks
Proportion of Participants Who Participated in Navigation Calls
The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported.
Measured: Up to 4 weeks
Proportion of Participants Using Instacart Vouchers
The proportion of participants who utilized the Instacart vouchers during the course of the study will be reported.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Stanford University
- Responsible party
- Sponsor
- Investigators
- Erin Van Blarigan, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602999
- Sponsor's protocol ID
- 24806
- Other IDs
- NCI-2024-07163, U54CA280811
- Status last verified
- May 2026
- First submitted
- 16 Sep 2024
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets will be shared with research collaborators
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
- ClinicalTrials.gov ID
- NCT06602999
- Acronym / sponsor ID
- 24806
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Stanford University
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the intervention's feasibility and acceptability.
SECONDARY OBJECTIVES:
- To estimate the effect of the intervention on adherence to American Cancer society nutrition guidelines.
II. To estimate the effect of the intervention on self-reported food insecurity.
III. To evaluate the feasibility of patient navigation calls. IV. To evaluate the feasibility of Instacart vouchers.
EXPLORATORY OBJECTIVE:
- To evaluate the feasibility of the intervention through an end-of-study semi-structured interview.
OUTLINE:
Patients receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Patients also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart once a week (QW) for 4 weeks.
After completion of study intervention, patients are followed up at 28 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (Instacart voucher, nutrition navigation) | Experimental | Other: Nutritional Intervention, Other: Instacart Voucher, Behavioral: Telephone-Based InterventionParticipants receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Participants also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18 years
- Diagnosis of a malignant cancer (except non-melanoma skin cancer).
- Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy, targeted therapies) during the study period. Hormonal therapies are allowed for patients with breast or prostate cancer
- At least 6 weeks since a major surgery and fully recovered.
- Have access to the internet and able to send and receive text messages.
Key exclusion criteria (3 listed)
- Contraindication to any study-related procedure or assessment.
- Planned major surgery or cancer-directed therapy during the study period.
- Living outside of the US or Canada during screening and/or the study period (outside the geographic areas that Instacart covers).
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 |
|---|---|---|
| Nutritional InterventionReceive a booklet on nutrition and physical activity for cancer survivors | Other | Supportive Care (Instacart voucher, nutrition navigation) |
| Instacart VoucherAlso: Nutritional InterventionReceive Instacart grocery delivery voucher | Other | Supportive Care (Instacart voucher, nutrition navigation) |
| Telephone-Based InterventionReceive nutrition navigation phone calls | Behavioural | Supportive Care (Instacart voucher, nutrition navigation) |
Primary outcome
Median Score on the Feasibility of Intervention Measure (FIM) Survey
Time frame: At 4 week assessment, 1 day
The FIM is a four-item measure of implementation that assesses participants perceived feasibility of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher values representing a greater feasibility. The intervention will be determined feasible if the overall median score is >= 4. The median and full range of the FIM scores will be reported.
Median Score on the Acceptability of Intervention Measure (AIM) Survey
Time frame: At 4 week assessment, 1 day
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a greater acceptability of the intervention. The intervention will be determined acceptable if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
Time frame: At 4 week assessment, 1 day
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a higher agreement with the appropriateness of the intervention. The intervention will be determined appropriate if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
8 secondary outcomes
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
Time frame: Up to 4 weeks
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
Time frame: Up to 4 weeks
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
Time frame: Up to 4 weeks
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
Time frame: Up to 4 weeks
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
Time frame: Up to 4 weeks
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
Time frame: Up to 4 weeks
Proportion of Participants Who Participated in Navigation Calls
Time frame: Up to 4 weeks
Proportion of Participants Using Instacart Vouchers
Time frame: Up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified datasets will be shared with research collaborators
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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. This study is not recruiting at the moment.
Erin Van Blarigan, ScD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention, Instacart Voucher and Telephone-Based Intervention in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of California, San Francisco at 2 sites 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Score on the Feasibility of Intervention Measure (FIM) Survey (time frame: At 4 week assessment, 1 day). The study lists 3 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 3 Jun 2026.