BfedBwell INSPIRE Pilot
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ Age 18-75 years
- ✓ BMI 25-45 kg/m2
- ✓ History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type
- ✓ In maintenance or surveillance status, defined as completion of active cancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy) with curative intent at least 3 months and no more than 10 years prior to enrollment or active surveillance with no treatment; ongoing targeted or hormone therapies ≥3 months prior to intervention start date and/or ongoing maintenance therapy ≥1 year is permitted (exceptions to this timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed active treatment or been in stable maintenance treatment prior to the intervention start date)
- ✓ Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions and who will provide clearance to participate in a nutrition and exercise program
- ✓ Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network (NCCN) guidelines (note: any positive responses will trigger a required physician clearance form)
- ✓ Speak English
- ✓ Have access to a computer or smart phone and Internet to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions
You may not qualify if…
- ✕ Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
- ✕ Actively undergoing chemotherapy, radiation, immunotherapy with curative intent or within 3 months of completion of surgery, chemotherapy, or radiation treatment or recent initiation of targeted/hormonal therapy (\<3 months) or maintenance therapy (\<1 year) unless well-tolerated and deemed acceptable by PI on a case-by-case basis
- ✕ Greater than 10 years post-active or maintenance therapy
- ✕ Plans to relocate within the next 6 months
- ✕ Plans for extended travel (\>2 weeks) within the next 6 months
- ✕ For females: (1) Currently pregnant or lactating, (2) Pregnant within the past 6 months, (3) Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception
- ✕ Any major surgery within the past 3 months or planned elective surgery during the intervention period, including mastectomy
- ✕ Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon)
Where it's recruiting
Aurora
Source: ClinicalTrials.gov · NCT07446595 · last updated 2026-04-28