Feasibility Outcomes of a Pilot Randomized Controlled Trial to Increase Cruciferous and Green Leafy Vegetable Intake in Post‐Treatment Head and Neck Cancer Survivors

Abstract

ObjectivePrevious research has shown higher intake of green leafy (GLV) and cruciferous vegetables (CV) are associated with improved biomarkers of prognosis and disease‐free survival in patients diagnosed with head and neck cancer (HNC). These observational study results have not yet been corroborated in a randomized controlled trial (RCT). The purpose of this study was to determine the feasibility of implementing a RCT to increase CV and GLV intake in post‐treatment HNC survivors.MethodsBetween January 2015 – April 2015, 17 post‐treatment HNC survivors were recruited via an institutional cancer registry and randomized to one of two groups: 1) an intervention group (n=9) that received weekly telephone dietary counseling aimed at reaching specific goals for weekly intake of CV (2.5 cups/week) and GLV (3.5 cups/week) or 2) a usual care attention control group (n=8). Participants completed a baseline survey, three 24‐hour dietary recalls, a blood draw, and anthropometric measures prior to randomization and at the end of the 12‐week study period. Feasibility outcomes included recruitment, retention, adherence, and safety. Retention was measured as the number completing the 12‐week study. Adherence was measured as completion of the weekly telephone sessions (for both groups) and self‐reported weekly CV and GLV intake for the intervention group.ResultsDuring the enrollment period, 350 incident HNC cases were screened for eligibility. Of these, n=98 were eligible for study participation and n=252 were ineligible. Reasons for ineligibility were “deceased” (n=93), “wrong/inactive numbers/unable to reach” (n=60) and “medical exclusions” (n=27). Of the n=98 eligible HNC cases, n=17 agreed to participate for an enrollment rate of 17.3%. The most common reason for non‐participation was “distance” (n=48). Other reasons for non‐participation included “not interested” (n=19) and “too busy” (n=5). Throughout the study period the retention rate was 100%. Mean intervention adherence rates for weekly goals were 68.7% for GLV, 66.6% for CV, and 66.9% overall. The mean adherence rate for completion of weekly telephone counseling was 92.5%. No serious adverse events were reported. Participants in the intervention group reported an overall mean increase of 4.4 and 2.9 cups of GLV and CV per week from baseline (pre‐intervention) intake, respectively.ConclusionThese results support the feasibility and acceptability of a post‐treatment intervention aimed at increasing CV and GLV intake in HNC survivors and suggest it may offer a promising strategy to improve vegetable consumption in this population. A larger RCT is warranted to assess the efficacy of this intervention on disease outcomes.Support or Funding InformationThis study was supported by a NIH/NCI Cancer Prevention and Control Training Grant: R25 CA047888 and a Research Enhancement Project Grant from the University of Alabama at Birmingham Center for Palliative and Supportive Care.