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Clinician-guided action plans and lifestyle coaching aim to improve sedentary time in childhood cancer survivorsNew plan to improve heart health in childhood cancer survivors

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Key Takeaway
Note that results are not yet available as this study is currently in the protocol phase for an ongoing trial.

This randomized controlled trial protocol describes an intervention for 374 childhood cancer survivors at increased risk of cardiovascular disease (CVD). The study aims to evaluate three specific strategies: a clinician-guided action plan, mobile health-supported goal setting, and intensive lifestyle coaching specifically for nonresponders.

The primary outcomes are sedentary time and Healthy Eating Index (HEI) scores. The target goals for these measures are a reduction of 0.35 SD (approximately 30 minutes per day) in sedentary time and an increase of 0.41 SD (approximately 4 points) in HEI scores. Secondary outcomes include assessing efficacy differences across strategies and identifying the most effective intervention sequences for diet quality and physical activity.

Follow-up is planned for 12 months. Because this is a protocol for an ongoing trial, no results regarding safety, tolerability, or primary outcome changes have been reported yet. The study will determine if these multi-component strategies can improve lifestyle factors in this high-risk population.

How this fits prior evidence

This protocol addresses a gap in evidence regarding specific behavioral interventions for childhood cancer survivors at risk of cardiovascular disease. While prior coverage noted that Mediterranean diet adherence is associated with reduced risk of several site-specific cancers and mortality, this trial specifically evaluates clinician-guided plans and lifestyle coaching to improve diet quality and reduce sedentary time in a high-risk survivor population.

Living with the long-term effects of childhood cancer often means facing a higher risk of heart disease. To address this, researchers are designing a study to see if specific interventions can help these survivors lead healthier lives.

The trial involves 374 participants who are at increased risk for cardiovascular disease. The team is testing three different approaches: a clinician-guided action plan, goal setting supported by mobile health tools, and intensive lifestyle coaching for those who need extra support. They want to see if these methods can reduce sedentary time and improve diet quality scores.

Because this is a protocol for an ongoing trial, the final results are not yet available. The study aims to find the best way to help survivors move more and eat better over a 12-month period. While we cannot know the outcomes yet, the goal is to provide clearer paths for managing heart health after cancer.

What this means for you:
A new trial is testing if mobile tools and coaching can improve diet and activity in childhood cancer survivors.

Common questions

Who is this study for?

This study focuses on people who have survived childhood cancer and are at an increased risk of cardiovascular disease. The goal is to see if specific coaching and mobile tools can help these survivors improve their daily habits, such as eating better and moving more.

What exactly is being tested?

The trial tests three different strategies: a clinician-guided action plan, goal setting through mobile health apps, and intensive coaching for those who need extra help. Researchers want to see if these methods can reduce sedentary time and improve Healthy Eating Index scores over 12 months.

Are the results available yet?

No, the results are not available yet because this is a protocol for an ongoing trial. The study is currently designed to determine if these specific intervention strategies can successfully improve physical activity and diet quality in survivors.

Study Details

Study typeRct
Sample sizen = 375
EvidenceLevel 2
Follow-up12.0 mo
PublishedAug 2026
View Original Abstract ↓
BACKGROUND: Survivors of childhood cancer have an increased risk of cardiovascular disease (CVD), but that risk may be reduced by healthy lifestyle behaviors. OBJECTIVE: Using a sequential multiple assignment randomized trial (SMART) design, this study aims to test different approaches to improve physical activity (PA) and diet quality among long-term survivors of cancer at increased risk of CVD over a 12-month period. The primary study outcomes are sedentary time and Healthy Eating Index (HEI) scores. METHODS: Participants were recruited from the Childhood Cancer Survivor Study cohort, with eligibility defined as current age of 18 to 54 years and at least one of three self-reported criteria: (1) <30 minutes per day of moderate to vigorous PA, (2) HEI-2015 score <60, or (3) BMI ≥25 kg/m2. Eligible participants completed baseline surveys, including a food frequency questionnaire, and had PA measured by research-grade accelerometry, and were then randomized to one of three conditions: (1) control, (2) clinician-guided action plan (sessions with the study provider every 2 months), or (3) mobile health-supported goal setting (weekly PA and monthly diet goals based on PA and diet tracker feedback). Following SMART principles, all participants' PA levels and HEI scores were reassessed after 3 months; participants from the 2 intervention groups who did not achieve ≥20-minute per day reduction in sedentary time or a ≥4-point increase in HEI score were classified as nonresponders and rerandomized to the alternative intervention or a more intensive lifestyle coaching intervention (weekly sessions with a study health coach). Intervention participants then entered a less intensive maintenance phase from months 7 to 12. All participants' PA levels and HEI scores were reassessed at 12 months. The target sample size was 375 participants, with 95 participants in the control group and 140 participants in each of the initial intervention groups, which will allow the study to detect changes of 0.35 SD (approximately 30 minutes per day) in sedentary time and 0.41 SD (approximately 4 points) in HEI score between the control and intervention groups (combined). Secondary analyses will test whether there are efficacy differences across intervention strategies, and which intervention sequences are associated with the greatest reduction in sedentary time and improvements in diet quality. RESULTS: From April 2022 to August 2025, the trial completed recruitment and randomized 374 participants out of 2268 approached. The last participant in this ongoing trial is expected to complete all procedures by the end of 2026, after which the final analyses will be conducted and the results will be reported. CONCLUSIONS: Future findings will inform whether any of these intervention strategies (and/or their combinations) can improve PA levels and diet quality in survivors of cancer at increased risk of CVD.
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