# Pragmatic Trial

> **NIH NIH P50** · NORTHWESTERN UNIVERSITY · 2022 · $293,728

## Abstract

Abstract - Pragmatic Clinical Trial
Cancer risk behaviors, including smoking, physical inactivity, and obesity, are individually associated with
reduced treatment response, side effects, heightened recurrence risk, decreased longevity, diminished quality
of life, and increased treatment cost for many cancers. These behaviors are at least as prevalent among
cancer patients and survivors as they are in healthy adults, but referral pathways to treat them are not routinely
integrated into cancer care. By integrating cancer risk behavior assessment into the electronic health record
system (EHR) and automating treatment referral, we plan to make telehealth-enabled treatment of health risk
behaviors (a clinical service called health promotion) accessible to cancer providers and patients throughout
the Center’s clinical practice network in a manner that is affordable, improves care quality, and is minimally
disruptive to existing clinical workflow. Our success in implementing patient-reported outcomes assessments
and EHR-supported smoking cessation, physical activity promotion, and obesity behavioral interventions
uniquely position us to integrate these services across the entire Northwestern Medicine (NM) oncology care
system using relatively few resources compared to in-person programs. We propose to build upon existing
NCI-funded tobacco cessation and symptom monitoring programs that are fully integrated into cancer by: 1)
adding brief screening for health risk behaviors, 2) augmenting the existing smoking auto-referral system to
include referral to a cancer-specific health promotion service that includes inactivity and obesity treatment; and
3) refining the symptom monitoring dashboard to include smoking, physical inactivity, and obesity. The Center
will deploy a 2-arm pragmatic clinical trial comparing a 12-month telehealth intervention for obesity, physical
inactivity, and tobacco use versus an enhanced usual care control condition. Participants (n=3000) will be
cancer survivors aged 18 or older who have at least one of the cancer risk factors. Treatment randomization
will be stratified by primary risk behavior, study site (Northwestern Memorial Hospital vs other NM hospital),
number of risk behaviors (1, 2 or 3), and cancer treatment (current treatment vs. not). Telehealth participants
will receive 20 calls or videos in English or Spanish, per patient preference, according to the following
schedule: weekly for 2 months, every other week for 4 months, monthly for 2 months, and every other month
for the final 4 months. Participants in the control arm will receive a pamphlet with local/national resources to
address their cancer risk behavior, which will be sent by either mail, email, or MyChart message depending on
patient preference. Assessments will be conducted by assessors, blinded to treatment arm, at baseline, 3, 6, 9,
and 12 months. We will evaluate treatment reach and its effects on the behaviors, care access and quality,
healthcare utilizati...

## Key facts

- **NIH application ID:** 10454619
- **Project number:** 1P50CA271353-01
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Bonnie Spring
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $293,728
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10454619

## Citation

> US National Institutes of Health, RePORTER application 10454619, Pragmatic Trial (1P50CA271353-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10454619. Licensed CC0.

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