BfedBwell INSPIRE: Impact of an Integrated Nutrition and Exercise Program for Post-treatment Survivors on Sleep Quality, Perceived Stress, and Biomarkers of Immune Dysregulation
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)
- •Not be planning for major elective surgery, to travel for \>2 consecutive weeks, or relocate/move during the intervention (\~6 months)
Exclusion Criteria
- •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)
- •Exclusion Criteria:
- •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
Arms & Interventions
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfedBwell - Core Curriculum (Behavioral)
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfedBwell - 1:1 Counseling (Behavioral)
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfedBwell - Group Support (Behavioral)
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfedBwell - Behavioral Skills (Behavioral)
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfedBwell - Technology (Behavioral)
BfedBwell INSPIRE Intervention
Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.
Intervention: BfitBwell - Clinical Exercise Program (Behavioral)
Outcomes
Primary Outcomes
Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention
Time Frame: 24 weeks
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll
Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention
Time Frame: 24 weeks
Adherence will be assessed as \[# sessions attended/# sessions provided\]
Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention
Time Frame: 24 weeks
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]
Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention
Time Frame: 24 weeks
Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants enrolled\]
Determine the intervention acceptability by participants during focus groups
Time Frame: 24 weeks
Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
Time Frame: 12 and 24 weeks
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.
Secondary Outcomes
- Measure changes in self-reported sleep quality(Baseline and 12 and 24 weeks)
- Measure changes in perceived stress(Baseline and 12 and 24 weeks)