Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer

Quality of life will be assessed using the Functional Assessment in Cancer Therapy - General (FACT-G). Developed by Cella et al. the FACT-G is a well validated and widely used multi-dimensional health related quality of life measure for cancer patients. It consists of 28 self-assessment items on a 5 point Likert scale that address four domains:

physical well-being, social/family well-being, emotional well-being, and functional well-being. Scores are calculated for each sub-scale per FACT scoring instructions and summed for a total score ranging between 0 and 108 with higher scores indicating a higher quality of life.

The Hospital Anxiety Depression Survey will be utilized to assess patient mood on this study. It is a validated, 14 item self-assessment tool used to assess severity of anxiety and depression symptoms in patients. Two 7 item subscales assess anxiety and depression in the past one week. Item responses are integer values between 0-3 and values for each subscale are added to give a subscale score. Scores on each subscale can range from 0 to 21 and a score greater than 11 is considered consistent with anxiety or depression. Scores of 7 or less are considered normal and scores of 8 to 10 are borderline. A score of 8 or greater on the anxiety subscale has a sensitivity of 0.9 and specificity of 0.78 for anxiety. Similarly, a score of 8 or greater on the depression subscale has a sensitivity of 0.83 and specificity of 0.79 for depression.

Weight is measured at each physician visit per hospital policy. Weight at each interval will be recorded in the electronic medical record (EMR). Should the patient not have a scheduled visit with their primary oncologist or registered dietitian within the required visit window, any weight recorded in the EMR within the visit window can be used. The changes in weight from baseline to 12 weeks,will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.

The change in nutritional status from baseline will be measured using the Abridged Patient Generated Subjective Global Assessment (abPG-SGA) in the 2 arms.

In 2014 a novel instrument to assess subjective financial toxicity, the Financial Toxicity Patient-Reported Outcome in Cancer measure (COST) was designed and recently validated. It is an 11 item assessment with 5 point Likert scale responses developed by de Souza et al reference to assess the levels of financial distress experienced by cancer patients. Each item response is scored 0-4 and then all individual item scores are summed. For incomplete surveys, the sum score is multiplied by 11 and then divided by the number of items answered. Total scores can range from 0-44 with higher scores representing higher subjective patient financial toxicity.

U.S. Adult Food Security Survey module to assess food security.It is a 10 item questionnaire developed by the US Department of Agriculture to specifically assess food insecurity in adults. Affirmative responses to each item are given one point. Total raw scores are calculated by adding all points (affirmative responses) and can range from 0-10. A raw score of zero is considered high food security. A raw score 1-2 is considered marginal food security. A raw score 3-5 is considered low food security and raw scores 6-10 are very low food security.