Medically Tailored Meals to Improve Cancer Outcomes
NCT07924241, Not applicable, Recruiting, Washington University School of Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Medically Tailored Meals to Improve Cancer Outcomes | ClinicalTrials.gov |
| NCT number | NCT07924241 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Washington University School of Medicine | ClinicalTrials.gov |
| Conditions | Cancer, Healthy Eating | ClinicalTrials.gov |
| Interventions | Medically Tailored Meals, Nutrition Education | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Enrollment Number | Start through completion of recruitment period (estimated to be 3-4 months) | Defined as the number of participants enrolled in the three-month stepdown intervention within the projected timeline (anticipated 60 participants). | ClinicalTrials.gov |
| Primary | Number of successful deliveries per participant of monthly food boxes and nutrition education components education components | From start to completion of the stepdown intervention (total time 3 months) | A delivery is counted as successful when the participant receives the monthly food box and nutrition education component, verified by delivery records and return of any undelivered materials to Food Outreach. | ClinicalTrials.gov |
| Primary | Number of Participants Completing Stepdown Intervention | At completion of stepdown intervention (total time 3 months) | ClinicalTrials.gov | |
| Primary | Participant satisfaction as assessed by Net Promoter Score (NPS) | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Participants will be asked one question: "How likely are you to recommend the Food Outreach stepdown program to a friend or someone in a similar situation?" rated 0 to 10. Scores of 9 to 10 are classified as promoters, 7 to 8 as passives, and 0 to 6 as detractors. NPS is the percentage of promoters minus the percentage of detractors (range -100 to +100); higher scores indicate greater satisfaction. At Visit 3 the question refers to the stepdown intervention. The same question about the 12-month MTM Cancer Program is asked at graduation (Visit 2) for comparison. | ClinicalTrials.gov |
| Primary | Participant experience as assessed by the MTM Program Experience and Satisfaction survey | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Participants rate five statements from strongly disagree (1) to strongly agree (5): the food met my dietary needs; the food tasted good; receiving the food helped me afford other things my household needed; the information and educational materials helped me eat a healthier diet; and the support from staff helped me manage my nutritional needs. Results will be reported as the proportion agreeing or strongly agreeing with each statement. Total scores range from 5-25. A higher score indicates higher satisfaction. | ClinicalTrials.gov |
| Primary | Changes in food insecurity as measured by the Food Security Survey | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Food insecurity is assessed by the six-item short form of the Food Security Survey Module by the United States Department of Agriculture (USDA). Questions address concerns about inability to afford food, skipping meals due to costs, and cutting meal sizes. The survey results in a score from 0-6 that is categorized as the following: 0-1 High or Marginal, 2-4 Low, and 5-6 Very Low. The higher the score, the greater the food insecurity. At the time of the enrollment into the 12-month MTM program, the Food Security Survey will be collected as part of the standard program enrollment procedures and is collected outside of participation in this trial. | ClinicalTrials.gov |
| Primary | Changes in nutrition security as measured by the four-item nutrition security screener | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Nutrition security is assessed with the four-item Household Nutrition Security measure, which asks about the past 12 months: eating foods that were not good for health and well-being because other foods were unavailable; worrying that the food eaten would hurt health and well-being; eating the same thing for several days in a row because of cost; and knowing what to eat for health but being unable to get healthful food. Each item is rated never, rarely, sometimes, often, or always. Items are scored from 4 (never) to 0 (always), and the measure score is the mean of the four item scores (range 0 to 4). A higher score indicates greater nutrition security, and a score of 2.00 or below is considered low. At the time of the enrollment into the 12-month MTM program, the nutrition survey will be collected as part of the standard program enrollment procedures and is collected outside of participation in this trial. | ClinicalTrials.gov |
| Primary | Changes in nutrition quality as assessed through Diet Quality Recall Survey | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | The Diet Quality Recall Survey is an assessment consisting of 5 questions evaluating nutrition quality. These nutritional quality questions include consumption over the past 3 months of non-starchy vegetables, fresh/frozen/canned fruit, whole grains, peanuts/almonds/walnuts/seeds/nuts, \& plant-based proteins with selection of everyday, most days (3+ days a week), sometimes (1-2 days a week), rarely (a couple times a month), \& never. The survey will be scored on a 5-point Likert scale from 1 (never) to 5 (everyday). Patients' responses will be summed, \& the means will be compared across time points. Total score ranges from 5-25. A higher score indicates more frequent consumption of non-starchy vegetables, fruit, whole grains, nuts and seeds, \& plant-based proteins. At the time of the enrollment into the 12-month MTM program, the Diet Quality Recall survey will be collected as part of the standard program enrollment procedures and is collected outside of participation in this trial. | ClinicalTrials.gov |
| Primary | Changes in dietary consumption as assessed through Food Outreach Cancer Client Nutrition Assessment Form | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Dietary consumption will be assessed through a diet recall where a patient will recall their typical daily dietary intake for breakfast, lunch, dinner, snacks, and fluids. A licensed dietitian will calculate caloric intake, protein intake, and fluid intake. Daily caloric intake: multiply a patient's body weight in kilograms x (25 to 30 kcal/kg) = number of kcal per day. The number of kcal per day varies depending on a patient's level of activity. Daily protein intake: multiply a patient's body weight in kg x (0.8 to 1.0 g/kg) = number of g of protein per day. Fluid intake: multiply the number of kcal consumed per day x 1 mL/kcal = number of mL of fluids per day. At the time of the enrollment into the 12-month MTM program, the Food Outreach Cancer Client Nutrition Assessment Form will be collected as part of the standard program enrollment procedures and is collected outside of participation in this trial. | ClinicalTrials.gov |
| Primary | Changes in participant self-efficacy score | At completion of the 12-month MTM program (enrollment in stepdown intervention - Visit 2) and 2-4 weeks after conclusion of stepdown intervention (Visit 3) (total time 3.5-4 months after enrollment) | Participant self-efficacy will be assessed through a two-question survey using a 5-point Likert scale. These questions address the ability to take care of daily nutrition-related needs and confidence in managing daily nutrition with selection of strongly disagree, disagree, neutral, agree, and strongly agree. The survey will be scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total score ranges from 2-10. A higher score indicates a higher self-efficacy. Patients' responses will be examined individually and summed, and the means will be compared across time points. | ClinicalTrials.gov |
| Secondary | Participant satisfaction as assessed through a semi-structured qualitative interview | At completion of the stepdown intervention (2-4 weeks after conclusion of the intervention) | Participant program satisfaction will be assessed through optional semi-structured qualitative interviews (no longer than 60 minutes) conducted after completion of the stepdown intervention. Example questions include: * What aspects of the MTM program made it easy to participate? What aspects made it difficult to participate? * What did you like about the meals that the program provided? * What didn't you like about the food/meals? What would you change? * What about the MTM program did you find the most useful in managing your cancer diagnosis? What was least helpful? * When the program ended, did you feel prepared to continue to manage your cancer diagnosis? In what ways? Participant responses will be audio recorded, transcribed, and analyzed using thematic analysis. Themes will be described narratively with illustrative quotes. The number of participants contributing to each theme will be reported descriptively and will not be used to indicate a theme's importance. | ClinicalTrials.gov |
| Secondary | Key informant perceptions of the implementation, effectiveness, and sustainability of the MTM program and stepdown intervention, assessed through semi-structured qualitative interviews | Up to 5 months from study launch | Up to 30 key informants (about 12 to 15 organization leaders and 12 to 15 referral partners) with past, current, or prospective involvement in the referral, delivery, funding, or organizational partnership of Food Outreach's MTM Cancer Program will complete one semi-structured interview of no longer than 60 minutes, by Zoom. The interview guide is informed by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and finalized with Program Advisory Committee input. Interviews will be audio recorded, transcribed, de-identified, and analyzed using thematic analysis. Themes will be described narratively with illustrative quotes. The number of key informants contributing to each theme will be reported descriptively and will not be used to indicate a theme's importance. Interviews are conducted on a rolling basis and are expected to be completed within approximately 4 to 5 months of launch. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)