Neoplasm MalignantSmall StepsNCT04987359
A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
A study testing Multimodal Lifestyle Program in people with Neoplasm Malignant, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- Multimodal Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Randomized 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.
- Conditions
- Neoplasm Malignant
- Being tested
- Multimodal Lifestyle Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Lifestyle ProgramBehavioural
The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Lifestyle Program | Experimental | 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. Receives: Behavioral: Multimodal Lifestyle Program |
| Waitlist Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness capacity (co-primary)
Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.
Measured: Baseline, Week 10
Change in body weight (co-primary)
Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.
Measured: Baseline, Week 10
Secondary outcomes (6)
Change in waist Circumference
Measured midway between the lower rib margin and the iliac crest.
Measured: Baseline, Week 10
Change in fat Mass
Measured by dual-energy x-ray absorptiometry
Measured: Baseline, Week 10
Change in systolic blood pressure
Seating, resting for 5 minutes before the measure is taken
Measured: Baseline, Week 10
Change in diastolic blood pressure
Seating, resting for 5 minutes before the measure is taken
Measured: Baseline, Week 10
Change in medication use
Medications related to cholesterol, diabetes, and blood pressure
Measured: Baseline, Week 10
Change in physical and mental quality-of-life
Assessed using the 36-Item Short Form Survey (SF-36)
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start19 Aug 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Brown, Pennington Biomedical Research Center
- Investigators
- Justin C Brown, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987359
- Sponsor's protocol ID
- PBRC 2021-013
- Acronym
- Small Steps
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025.
PubMed 41114371
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
- ClinicalTrials.gov ID
- NCT04987359
- Acronym / sponsor ID
- Small Steps / PBRC 2021-013
- Conditions
- Neoplasm Malignant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Lifestyle Program | Experimental | Behavioral: Multimodal Lifestyle ProgramThe 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. |
| Waitlist Control | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Lifestyle ProgramThe multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. | Behavioural | Multimodal Lifestyle Program |
Primary outcome
Change in cardiorespiratory fitness capacity (co-primary)
Time frame: Baseline, Week 10
Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.
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.
6 secondary outcomes
Change in waist Circumference
Time frame: Baseline, Week 10
Change in fat Mass
Time frame: Baseline, Week 10
Change in systolic blood pressure
Time frame: Baseline, Week 10
Change in diastolic blood pressure
Time frame: Baseline, Week 10
Change in medication use
Time frame: Baseline, Week 10
Change in physical and mental quality-of-life
Time frame: Baseline, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 41114371Brown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin C Brown, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Lifestyle Program in people with Neoplasm Malignant, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness capacity (co-primary) (time frame: Baseline, Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.