Cancer SurvivorLEAPNCT06868524
Leading Healthy Eating and Activity Promotion Program
A study testing LEAP Program in people with Cancer Survivor and Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Cancer, Oncology
- What is being tested?
- LEAP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 89
- English speaking
- Resident of Birmingham area or surrounding community
- History of any type of cancer or the friend or family with of a cancer survivor
Who cannot join
- Serious difficulty hearing
- History of dementia or organic brain syndrome
- On primary treatment for cancer
- No other other medical, psychological, or social characteristic that would interfere with participation in evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35243
Sydney McGlawn, 205-934-8821, sburdette@uabmc.edu
Marie-Therese Cooper, 205-934-6897, marietheresejcooper@uabmc.edu
About this study
Official title: Leveraging Adaptation and Multilevel Implementation Strategies to Address Unique Health Promotion Challenges Among Cancer Survivors
The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.
- Conditions
- Cancer Survivor, Cancer, Oncology
- Being tested
- LEAP Program
- Keywords
- cancer survivor, cancer, oncology, exercise, nutrition, diet, healthy lifestyle, behavior change
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAP ProgramBehavioural
Combines a publicly available website with educational materials related to healthy eating, regular exercise, and a healthy body weight. Interested community members can also join optional in person community-based events that reinforce the educational material on the website.
| Study group | Role | What they receive |
|---|---|---|
| Program participants | Experimental | Agree to evaluate a community-based, publicly available program combining a website with optional in person group sessions. Receives: Behavioral: LEAP Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly intake of vegetables, fruit, and sugar sweetened beverages
Each participant reports the average times per week they eat vegetables, eat fruit, and drink sugar sweetened beverages
Measured: Baseline, 12 weeks
Average time spent doing physical activity based on accelerometer
Measuring physical activity from one-week of wearing an accelerometer
Measured: Baseline, 12 weeks
Body mass index (BMI)
Trained research staff will measure height using portable stadiometer (baseline only; no shoes) and weight using portable calibrated scale (light clothing without shoes) to calculate BMI (weight in kg/height in meters squared)
Measured: Baseline, 12 weeks
Secondary outcomes (4)
Overall quality of life score
self reported survey to collect data about physical, mental, and social health on a scale of 1 to 5 with 5 being excellent and 1 being poor
Measured: Baseline, 12-weeks
Self-report physical activity
Participants report time per day or week doing moderate intensity physical activity, doing vigorous intensity physical activity, walking, and sitting.
Measured: Baseline, 12 weeks
Evaluation of the LEAP Program
Participants complete a survey about the LEAP Program activities they did and feedback on the program
Measured: 12 weeks
Physical performance
Number of times a participant can stand up from a chair in 30 seconds and the time it takes for a participant to stand up from a chair, walk 10 feet, and return to sit in the chair
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start30 Oct 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Rogers, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868524
- Sponsor's protocol ID
- IRB-300010921
- Other IDs
- 1U54CA280770-01
- Acronym
- LEAP
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individuals interested in requesting IPD should contact the study PIs.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Adaptation and Multilevel Implementation Strategies to Address Unique Health Promotion Challenges Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT06868524
- Acronym / sponsor ID
- LEAP / IRB-300010921
- Conditions
- Cancer Survivor, Cancer, Oncology
- Keywords
- cancer survivor, cancer, oncology, exercise, nutrition, diet, healthy lifestyle, behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 11 Mar 2025 (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.
The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Program participants | Experimental | Behavioral: LEAP ProgramAgree to evaluate a community-based, publicly available program combining a website with optional in person group sessions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 89
- English speaking
- Resident of Birmingham area or surrounding community
- History of any type of cancer or the friend or family with of a cancer survivor
Key exclusion criteria (4 listed)
- Serious difficulty hearing
- History of dementia or organic brain syndrome
- On primary treatment for cancer
- No other other medical, psychological, or social characteristic that would interfere with participation in evaluation
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 |
|---|---|---|
| LEAP ProgramCombines a publicly available website with educational materials related to healthy eating, regular exercise, and a healthy body weight. Interested community members can also join optional in person community-based events that reinforce the educational material on the website. | Behavioural | Program participants |
Primary outcome
Weekly intake of vegetables, fruit, and sugar sweetened beverages
Time frame: Baseline, 12 weeks
Each participant reports the average times per week they eat vegetables, eat fruit, and drink sugar sweetened beverages
Average time spent doing physical activity based on accelerometer
Time frame: Baseline, 12 weeks
Measuring physical activity from one-week of wearing an accelerometer
Body mass index (BMI)
Time frame: Baseline, 12 weeks
Trained research staff will measure height using portable stadiometer (baseline only; no shoes) and weight using portable calibrated scale (light clothing without shoes) to calculate BMI (weight in kg/height in meters squared)
4 secondary outcomes
Overall quality of life score
Time frame: Baseline, 12-weeks
Self-report physical activity
Time frame: Baseline, 12 weeks
Evaluation of the LEAP Program
Time frame: 12 weeks
Physical performance
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. Individuals interested in requesting IPD should contact the study PIs.
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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.
Laura Rogers, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAP Program in people with Cancer Survivor and Cancer, run by University of Alabama at Birmingham 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney McGlawn (205-934-8821, sburdette@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly intake of vegetables, fruit, and sugar sweetened beverages (time frame: Baseline, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.