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Marisa Bittoni
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P40 - Risk Reduction and Tobacco Control (ID 172)
- Event: WCLC 2020
- Type: Posters
- Track: Risk Reduction and Tobacco Control
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P40.03 - Report on a Phytochemical-rich Dietary Intervention Trial to Prevent Lung Cancer: Implementation in a High-Risk Lung Screening Clinic (ID 3821)
00:00 - 00:00 | Presenting Author(s): Marisa Bittoni
- Abstract
Introduction
The BeWell Trial, Black Raspberry Beverage for the Prevention of Lung Cancer, is currently underway at The Ohio State University (OSU) James Cancer Hospital. The study is a placebo-controlled, randomized, cross-over pilot study to assess the impact of a novel black raspberry food product on the microbiome and immune functions in a high risk cohort for lung cancer. Our central hypothesis is that phytochemical–rich black raspberries (BRB) will increase the diversity of the gut microbiome, increase the abundance of specific desirable microbes, such as Akkermansia muciniphila, and inhibit cancer by indirect effects on host inflammatory cascades, perhaps via impact on the microbiota. This report will describe the trial progress, including challenges in accrual/retention, compliance, safety, and additional insights on conducting BRB and cancer trials.
Methods
BeWell Study participants are recruited from the OSU Lung Screening Clinic, pulmonary clinics, and social media (e.g. Facebook). Inclusion criteria include: age 55-77 years, 30+ pack years smoking history, and smoked within the last 15 years. Exclusion criteria include: oral corticosteroid use and uncontrolled gastrointestinal or metabolic disorders. Participants are asked to follow a low-phenolic diet and we obtain a 24-hour urine sample, stool sample, blood draw and weight/vitals at each clinic visit. They are randomized to receive the BRB or placebo beverage, (blocked by gender and smoking status) for 4-weeks (170 ml, 2X/day), have a 2-week washout period, and then cross-over to 4 weeks of BRB or placebo (10 weeks total). The crossover design greatly minimizes variation, which is particularly beneficial in microbiome studies. Participants also complete diet compliance, medical history, food frequency and physical activity questionnaires.
Results
Of the accrual target of 42 patients, 32 have been fully consented, and 2 have fully completed the 10-week study. Thirteen individuals are former smokers (6 females and 7 males), with 7 current smokers (all female). Their ages range from 58 to 76 years. The dropout rate is 37%. Participants mostly dropped out before the first study visit. Nearly half of dropouts occurred during the holidays. We have approached 244 eligible participants who declined (13% consent rate). The reasons given for non-participation include: not interested, too busy, hard to get to appointments, dislike home urine/stool tests, live too far and work conflicts. One adverse event was reported event (diarrhea). Current accrual rates suggest study completion in December, 2020.
Conclusion
The accrual and retention process for this study of high risk smokers has been challenging, with 13% of individuals agreeing to enroll and high dropout rate (37%). As a result, we extended our estimated recruiting period from 6 to 12 months, increased the compensation level and increased the number of targeted advertisements on social media, with A/B testing to optimize text and images. Objective measures of various recruitment and advertising success are being captured. We suggest that future trials with similar groups consider time of year and season when recruiting, ensure adequate reimbursement and offer any possible incentives or conveniences to increase participation and retention, thus increasing the success of similar future trials.
