BfedBwell INSPIRE: Impact of an Integrated Nutrition and Exercise Program for Post-treatment Survivors on Sleep Quality, Perceived Stress, and Biomarkers of Immune Dysregulation
Summary
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.
Detailed description
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month single-arm study of the augmented BfedBwell + BfitBwell interventions. Feasibility and acceptability of integrating commercially-available wearable technology and smart scales will be evaluated. The study will also explore preliminary changes in sleep quality, perceived stress, and physiological indicators of stress and immune function.
Arms & interventions
- BehavioralBfedBwell - Core Curriculum
Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship
- BehavioralBfedBwell - 1:1 Counseling
Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers
- BehavioralBfedBwell - Behavioral Skills
Group-based behavioral skills development sessions and cooking demonstrations to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading)
- BehavioralBfedBwell - Group Support
Structured group support sessions to share experiences
- BehavioralBfedBwell - Technology
Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight
- BehavioralBfitBwell - Clinical Exercise Program
Supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations
Outcome measures
Primary
Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll
Time frame: 24 weeks
Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention
Adherence will be assessed as \[# sessions attended/# sessions provided\]
Time frame: 24 weeks
Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]
Time frame: 24 weeks
Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention
Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants enrolled\]
Time frame: 24 weeks
Determine the intervention acceptability by participants during focus groups
Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.
Time frame: 24 weeks
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters - % detractors. NPS scores range from -100 to +100, with scores \>/=0 indicating good acceptability.
Time frame: 12 and 24 weeks
Secondary
Measure changes in self-reported sleep quality
Time frame: Baseline and 12 and 24 weeks
Measure changes in perceived stress
Time frame: Baseline and 12 and 24 weeks
Eligibility criteria
Study locations (1)
University of Colorado Cancer Center
Aurora, Colorado, 80045