Trial Outcomes & Findings for Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity (NCT NCT06602999)
NCT ID: NCT06602999
Last Updated: 2026-06-03
Results Overview
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.
COMPLETED
NA
40 participants
At 4 week assessment, 1 day
2026-06-03
Participant Flow
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.
Participant milestones
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
Baseline characteristics by cohort
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=40 Participants
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.
|
|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 12.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: At 4 week assessment, 1 dayPopulation: Only 38 of the participants completed the 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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=38 Participants
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.
|
|---|---|
|
Median Score on the Feasibility of Intervention Measure (FIM) Survey
|
5 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: At 4 week assessment, 1 dayPopulation: Only 38 of the participants completed the 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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=38 Participants
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.
|
|---|---|
|
Median Score on the Acceptability of Intervention Measure (AIM) Survey
|
5 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: At 4 week assessment, 1 dayPopulation: Only 38 of the participants completed the 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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=38 Participants
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.
|
|---|---|
|
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
|
4.5 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: One participant did not complete this questionnaire
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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=39 Participants
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.
|
|---|---|
|
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
|
-0.03 intake units (servings) per day
Interval -0.14 to 0.0
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: One participant did not complete this questionnaire
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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=39 Participants
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.
|
|---|---|
|
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
|
0 intake units (servings) per day
Interval -0.08 to 0.0
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: One participant did not complete this questionnaire
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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=39 Participants
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.
|
|---|---|
|
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
|
0.04 ounce equivalents per day
Interval -0.04 to 0.29
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: One participant did not complete this questionnaire
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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=39 Participants
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.
|
|---|---|
|
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
|
-0.07 teaspoons of sugar from drinks per day
Interval -0.32 to 0.0
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: One participant did not complete this questionnaire
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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=39 Participants
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.
|
|---|---|
|
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
|
0.4 intake units (cup equivalents) per day
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Only 38 of the participants completed the 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.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=38 Participants
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.
|
|---|---|
|
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
|
-1.11 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: The proportion reported is the proportion of all participants available to be contacted for that call.
The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=40 Participants
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.
|
|---|---|
|
Proportion of Participants Who Participated in Navigation Calls
Participated in 4 of 4 calls total
|
0.60 proportion of participants
|
|
Proportion of Participants Who Participated in Navigation Calls
Participated in < 2 of 4 calls total
|
0.00 proportion of participants
|
|
Proportion of Participants Who Participated in Navigation Calls
Participated in 2 of 4 calls total
|
0.10 proportion of participants
|
|
Proportion of Participants Who Participated in Navigation Calls
Participated in 3 of 4 calls total
|
0.30 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksThe proportion of participants who utilized the Instacart vouchers during the course of the study will be reported.
Outcome measures
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=40 Participants
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.
|
|---|---|
|
Proportion of Participants Using Instacart Vouchers
|
1.00 proportion of participants
|
Adverse Events
Supportive Care (Instacart Voucher, Nutrition Navigation)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supportive Care (Instacart Voucher, Nutrition Navigation)
n=40 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
30.0%
12/40 • Number of events 12 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
40.0%
16/40 • Number of events 16 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Flatulence
|
42.5%
17/40 • Number of events 17 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Abdominal distension
|
65.0%
26/40 • Number of events 26 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Constipation
|
67.5%
27/40 • Number of events 27 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
14/40 • Number of events 14 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Gastrointestinal disorders
Abdominal Pain
|
47.5%
19/40 • Number of events 19 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
35.0%
14/40 • Number of events 14 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
70.0%
28/40 • Number of events 28 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
62.5%
25/40 • Number of events 25 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Vascular disorders
Hot Flash
|
2.5%
1/40 • Number of events 1 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.5%
1/40 • Number of events 1 • Up to 4 weeks
A Recent Health Survey with modified questions from the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Measurement System will be used to collect adverse events from participants by self-report. Participants report the severity, frequency, and amount of interference of unexpected symptoms based on a 4-week recall period. Nutrition navigators also asked participants if they have experienced any health events during the weekly check ins.
|
Additional Information
Dr. Erin Van Blarigan, ScD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place