Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Keywords
Nutrition
Brief 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. 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: I. To determine the intervention's feasibility and acceptability. SECONDARY OBJECTIVES: I. 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: I. 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.
Interventions
OTHERNutritional Intervention
Receive a booklet on nutrition and physical activity for cancer survivors
OTHERInstacart Voucher
Receive Instacart grocery delivery voucher
BEHAVIORALTelephone-Based Intervention
Receive nutrition navigation phone calls
Sponsors
University of California, San Francisco
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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).
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Score on the Feasibility of Intervention Measure (FIM) Survey | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time | Up to 4 weeks | 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. |
| Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time | Up to 4 weeks | 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. |
| Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time | Up to 4 weeks | 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. |
| Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time | Up to 4 weeks | 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. |
| Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time | Up to 4 weeks | 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. |
| Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire | Up to 4 weeks | 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. |
| Proportion of Participants Who Participated in Navigation Calls | Up to 4 weeks | The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported. |
| Proportion of Participants Using Instacart Vouchers | Up to 4 weeks | The proportion of participants who utilized the Instacart vouchers during the course of the study will be reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErin Van Blarigan, ScD
University of California, San Francisco
Participant flow
Pre-assignment details
Forty-two potential participants consented but two did not complete the baseline surveys required in order to be assigned to the study intervention before the last date of enrollment. These two participants were not considered enrolled even though informed consent was signed due to the fact no study intervention was assigned nor received by these participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 28 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed