Actively Recruiting
BfedBwell INSPIRE: Integrated Nutrition and Exercise Program for Post-treatment Cancer Survivors Impact on Sleep Quality, Stress, and Immune Biomarkers
Led by University of Colorado, Denver · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
American Institute for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility and acceptability of a comprehensive lifestyle intervention for cancer survivors who are overweight or obese and have completed active treatment. The study focuses on improving nutrition, exercise, sleep health, and stress management by integrating two programs: the BfedBwell survivorship nutrition program and the BfitBwell clinical exercise oncology program. It also explores preliminary changes in sleep quality, perceived stress, and biomarkers related to stress and immune function. Participants will undergo a 6-month single-arm intervention combining nutrition education, individual counseling, behavioral skills development, group support, and the use of wearable technology and smart scales to monitor physical activity, sleep, and body weight. The exercise component includes supervised sessions led by a cancer exercise specialist based on established physical activity guidelines for cancer survivors. The nutrition program involves group education, 1:1 dietitian counseling, cooking demonstrations, and behavioral techniques. During the study, participants will attend weekly group education and support sessions, monthly behavioral skills and counseling sessions, and up to two exercise sessions per week initially, tapering to once monthly supervised and weekly virtual sessions in the later 12 weeks. Researchers will assess recruitment, adherence, retention, and acceptability of the intervention over 24 weeks. They will also measure changes in sleep quality and perceived stress at baseline, 12 weeks, and 24 weeks to evaluate the intervention's impact.
CONDITIONS
Brief Title
BfedBwell INSPIRE Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- Body mass index (BMI) between 25 and 45 kg/m2
- History of adult cancer diagnosed within the past 10 years
- Completed active cancer therapy with curative intent at least 3 months and no more than 10 years ago or in stable maintenance therapy
- Have a primary care provider willing to clear participation in nutrition and exercise program
- Ability and willingness to participate in supervised exercise as assessed by physical activity readiness questionnaires
- Speak English
- Access to a computer or smartphone with Internet for online sessions and questionnaires
- Live or work within 30 miles of the study center (exceptions possible)
- No plans for major surgery, travel over 2 consecutive weeks, or relocation during the 6-month intervention
- No nicotine or tobacco use within past 6 months
- Agree to avoid nutritional supplements except physician-prescribed during the study
- Capable and willing to give informed consent
- Willing to attend weekly group education, monthly behavioral skills and counseling sessions, and exercise sessions as scheduled
- Not meeting dietary or physical activity guidelines unless highly motivated
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
- Actively undergoing chemotherapy, radiation, or immunotherapy within 3 months or recent initiation of targeted/hormonal/maintenance therapy unless well tolerated
- More than 10 years post-active or maintenance therapy
- Plans to relocate or travel over 2 weeks in next 6 months
- For females: currently pregnant, lactating, recently pregnant within 6 months, or planning pregnancy within 18 months unless surgically sterilized or using reliable contraception
- Major surgery within past 3 months or planned elective surgery including mastectomy during intervention
- Prior surgeries affecting digestion or metabolism significantly
- Recent acute cardiovascular events or symptoms suggestive of cardiovascular disease
- Uncontrolled hypertension or abnormal resting heart rate on screening
- Diabetes unless well controlled on specific medications with HbA1c below 8%
- Uncontrolled thyroid disorders
- Very high triglycerides or LDL cholesterol on screening
- Other significant metabolic or chronic health problems impacting safe participation
- Recent start of lipid-lowering, hypertension, or oral hypoglycemic medications
- Use of medications affecting weight or appetite except specific cancer treatments
- Recent systemic glucocorticoid use except physiologic replacement
- Previous obesity surgeries or devices within 1 year except specific exceptions
- Current or recent participation in formal nutrition, weight loss, or physical activity programs or trials
- Prior participation in the BfitBwell exercise program within 3 years unless exception granted
- Nicotine or tobacco use within past 6 months
- Current alcohol or substance abuse
- History or signs of eating disorders requiring further medical assessment
- Severe or recent depression interfering with participation
- Other significant psychiatric illnesses affecting adherence
- Medical or physical limitations to exercise or high risk per guidelines
- Cognitive inability to consent or participate safely
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants engage in a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. This includes weekly group education sessions, monthly behavioral skills and 1:1 counseling sessions, group support, and use of wearable devices for self-monitoring of physical activity, sleep, and body weight.
Weekly group sessions, monthly counseling and skills sessions, and regular exercise sessions as scheduled
Trial Site Locations
Total: 1 location
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Melissa Mamele, MS, RD, CSCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here