Medically Tailored Meals to Improve Cancer Outcomes

Participants will be provided with monthly food boxes and tailored nutrition education over three months following graduation from the Food Outreach MTM Cancer Program.

Participants will be contacted by program staff, at the point of graduation of a 12-month MTM Cancer program prior to starting the stepdown intervention, and again following completion of the 3-month stepdown intervention. Contact will be made via phone, in person, or by electronic communication.

Following completion of the stepdown intervention, participants will be invited to complete an optional semi-structured qualitative interview. Participant data from their enrollment into the original 12 month program will also be shared with the research team.

Participants will receive medically tailored meals monthly through Food Outreach for three months after graduation from the MTM Cancer Program. MTM are designed by a registered dietitian and include frozen medically tailored meals, medically tailored groceries and fresh produce tailored for each participant.

Nutrition education will be provided by a registered dietitian and designed to support the transition to independent healthy eating during cancer survivorship. Nutrition education materials were developed by Food Outreach.

Key informant interviews will be conducted on a rolling basis n=12-15 organization leaders, n=12-15 referral partners). All interviews are expected to take no more than 60 minutes and will be conducted by a trained study team member using a semi-structured interview guide. Key informants will be asked how they perceive the implementation, effectiveness, and sustainability of the MTM program and stepdown intervention.

Defined as the number of participants enrolled in the three-month stepdown intervention within the projected timeline (anticipated 60 participants).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.