BfedBwell INSPIRE Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Willing to attend weekly small group education sessions, monthly behavioral skills development sessions, weekly group support sessions, and monthly 1:1 counseling sessions with a registered dietitian (RD)
Willing to attend up to two BfitBwell exercise sessions (one in person supervised, one virtual unsupervised) per week for first 12 weeks then once monthly supervised and once weekly unsupervised virtual sessions for second 12 weeks
Not meeting dietary guidelines [i.e., Healthy Eating Index (HEI) score <80 as assessed via NCI DHQ III food frequency questionnaire] or physical activity guidelines [i.e., <150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire] (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
Trial design
Treatments tested in this trial
- BfedBwell - Core Curriculum
- BfedBwell - 1:1 Counseling
- BfedBwell - Behavioral Skills
- BfedBwell - Group Support
- BfedBwell - Technology
- BfitBwell - Clinical Exercise Program
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Colorado, Denver
Lead sponsor
American Institute for Cancer Research
Collaborator
Source ClinicalTrials.gov