AYA STEPS

Christine Hill-Kayser, MD

The proposed project will leverage two programs of research at UPenn and CHOP that are delivering technology-based interventions to adolescent and young adult (AYA) cancer survivors.

In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC). They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that will provide tailored messages to enhance uptake of their care plan.

AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors

Abramson Cancer Center at Penn Medicine

Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Rare Diseases

Chronic Disease

Prediabetic State

Glucose Intolerance

Diabetes Mellitus

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Chronic Graft Versus Host Disease

Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.

Participants randomized to the control arm will only wear a CGM.

The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.

Glucose-Guided Eating with CGM

Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

CGM only

Princess M Georges

Megan Roy

Susan M Schembre

Nina Kadan-Lottick

This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight.

The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.

Glucose-Guided Eating Pilot

Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study

The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.

Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.

Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.

The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.

GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).

GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).

Changes in body weight will be measured using calibrated digital scales (measured in kilograms).

Changes in insulin resistance will be measured as homeostatic model assessment for insulin resistance (HOMA-IR). It will be computed from fasting insulin and fasting glucose (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5).

Changes in glycemic variability will be assessed from CGM data using the freely accessible EasyGV software available from the University of Oxford (https://www.phc.ox.ac.uk/research/resources/easygv).

Changes in oxidative stress will be measured as 8-isoprostane from spot urine.

Changes the sRAGE was measured in serum by ELISA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors	NCT03363711	Adolescent and ...	AYA STEPS	15 Years - 29 Years	Abramson Cancer Center at Penn Medicine
Glucose-Guided Eating Pilot	NCT05998460	Postmenopausal Prediabetes Adolescent and ...	Glucose-Guided ... CGM only	18 Years -	Georgetown University

Spots Global Cancer Trial Database for adolescent and young adult (aya) cancer survivors