Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04987359

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

To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent before any trial-related activities
  • History of any malignancy
  • Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
  • No evidence of residual or recurrent cancer under active treatment
  • Age ≥18 years
  • Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
  • Willing to be randomized
  • Allow the collection and storage of biospecimens and data for future use

Exclusion criteria

  • Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
  • Significant purposeful weight loss (>11 kg) within the past 12 weeks
  • Current use of medications or devices for the purpose of weight loss
  • Metabolic or bariatric surgery within the last year
  • Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
  • Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
  • Psychiatric disorders or conditions that would preclude participation in the study intervention
  • Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study

Treatment and study plan

Multimodal Lifestyle Program

Behavioral

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.

Primary outcomes

  1. Change in cardiorespiratory fitness capacity (co-primary)

    Time frame: Baseline, Week 10

    Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.

  2. Change in body weight (co-primary)

    Time frame: Baseline, Week 10

    Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.

Secondary outcomes

  1. Change in waist Circumference

    Time frame: Baseline, Week 10

    Measured midway between the lower rib margin and the iliac crest.

  2. Change in fat Mass

    Time frame: Baseline, Week 10

    Measured by dual-energy x-ray absorptiometry

  3. Change in systolic blood pressure

    Time frame: Baseline, Week 10

    Seating, resting for 5 minutes before the measure is taken

  4. Change in diastolic blood pressure

    Time frame: Baseline, Week 10

    Seating, resting for 5 minutes before the measure is taken

  5. Change in medication use

    Time frame: Baseline, Week 10

    Medications related to cholesterol, diabetes, and blood pressure

  6. Change in physical and mental quality-of-life

    Time frame: Baseline, Week 10

    Assessed using the 36-Item Short Form Survey (SF-36)

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: Small Steps

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.