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Behavioral Intervention

Lifestyle Intervention for Cancer Survivors (Small Steps Trial)

N/A

Recruiting

Led By Justin C Brown, PhD

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of any malignancy

No evidence of residual or recurrent cancer under active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 10

Awards & highlights

Small Steps Trial Summary

This trial looks at whether a 10-week program of exercise and healthy eating can help cancer survivors improve their fitness and lose weight.

Who is the study for?

This trial is for adult cancer survivors who are not currently undergoing active treatment and have no evidence of remaining or returning cancer. Participants should be overweight, with a BMI ≥30 kg/m2 or ≥27 kg/m2 if they also have weight-related health issues. They must not exercise regularly, be pregnant, or have conditions that would make the lifestyle program unsafe.Check my eligibility

What is being tested?

The study tests a 10-week multimodal lifestyle program aimed at improving fitness and reducing body weight in cancer survivors. Participants will either start the program immediately or be placed on a waitlist (control group) to compare outcomes between the two groups.See study design

What are the potential side effects?

Since this intervention involves lifestyle changes like diet and exercise rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but are generally expected to be minimal.

Small Steps Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had cancer before.

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I currently have no signs of cancer returning or remaining.

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I am 18 years old or older.

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My BMI is 30 or higher, or it's 27 or higher with weight-related health issues.

Small Steps Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in body weight (co-primary)

Change in cardiorespiratory fitness capacity (co-primary)

Secondary outcome measures

Change in diastolic blood pressure

Change in fat Mass

Change in medication use

+3 more

Small Steps Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Lifestyle ProgramExperimental Treatment1 Intervention

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.

Group II: Waitlist ControlActive Control1 Intervention

The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

305 Previous Clinical Trials

181,982 Total Patients Enrolled

Justin C Brown, PhDPrincipal InvestigatorPennington Biomedical Research Center

Media Library

Multimodal Lifestyle Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04987359 — N/A

Cancer Research Study Groups: Multimodal Lifestyle Program, Waitlist Control

Cancer Clinical Trial 2023: Multimodal Lifestyle Program Highlights & Side Effects. Trial Name: NCT04987359 — N/A

Multimodal Lifestyle Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987359 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this medical trial's participants?

"Affirmative, the information on clinicaltrials.gov verifies that this trial is open for recruitment. The study was initially posted on August 19th 2021 and most recently updated on February 7th 2022. It seeks 54 individuals from a single site."

Answered by AI

What aims is this trial attempting to accomplish?

"During the Baseline and Week 10 period, researchers will primarily evaluate a Change in body weight as co-primary outcome. Other secondary outcomes to be monitored include Changes in systolic blood pressure (taken after 5 minutes of rest), fat Mass measured with dual energy x-ray absorptiometry, and physical/mental quality-of life assessed by administering SF-36 surveys."

Answered by AI

Are there still vacancies available for participation in this trial?

"Per the information hosted on clinicaltrials.gov, this medical research is currently seeking participants. The trial was initially listed on August 19th 2021 and revised most recently on February 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer

Justin Brown 2021. "A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987359.