Cancer, Survivorship
Conditions
Keywords
Overweight, Obesity, Diet, food, and nutrition, Exercise, Healthy lifestyle behaviors, Cancer
Brief summary
Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program.
Detailed description
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell intervention. 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 cluster-randomized 2\^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
Interventions
BEHAVIORALBfedBwell - Core Curriculum
12-week core nutrition education curriculum + 12-week tapered maintenance curriculum
BEHAVIORALBfedBwell - 1:1 Counseling
Individual 1:1 counseling sessions with a registered dietitian
BEHAVIORALBfedBwell - Behavioral Skills
Group-based behavioral skills development sessions
BEHAVIORALBfedBwell - Group Support
Structured group support sessions
BEHAVIORALProgram delivery
Delivery and evaluation of one or more intervention components
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
For program delivery staff: 1. Men and women 2. Age ≥ 18 years 3. Speak English 4. Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs For intervention participants: 1. Men and women 2. Age 18-75 years 3. BMI 25-45 kg/m2 4. History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type 5. 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) 6. 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 7. 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) 8. Speak English 9. 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 10. 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) 11. Not be planning for major elective surgery, to travel for \>2 consecutive weeks, or relocate/move during the intervention (\~6 months) 12. No nicotine or tobacco use within previous 6 months 13. Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study 14. Capable and willing to give informed consent and understand
Exclusion criteria
15. Willing to attend weekly small group education sessions and some, none, or all of the following: monthly behavioral skills development sessions, weekly group support sessions and/or monthly 1:1 counseling held by a registered dietitian (RD) 16. Willing to attend up to two BfitBwell exercise sessions (one in person, one virtual) per week for first 12 weeks then once monthly in person and once weekly virtual sessions for second 12 weeks 17. 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 \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention | 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 BfedBwell nutrition intervention | 24 weeks | Adherence will be assessed as \[# sessions attended/# sessions provided\] for each BfedBwell component. |
| Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention | 24 weeks | Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]. |
| Determine the research protocol retention feasibility of the BfedBwell nutrition intervention | 24 weeks | Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants randomized\]. |
| Determine the intervention acceptability by participants during focus groups | 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 feasibility by program delivery staff using Feasibility of Intervention Measure (FIM) | 12 and 24 weeks | Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility. |
| Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM) | 12 and 24 weeks | Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability. |
| Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM) | 12 and 24 weeks | Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness. |
| Determine the intervention acceptability by participants using the Net Promoter Score (NPS) | 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 \&amp;amp;gt;0 indicating good acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations | 12 and 24 weeks | Determine the change in adherence to cancer survivorship guidelines as measured by World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) scoring criteria. Scores range from 0 to 7 points. A higher score reflects greater adherence to the recommendations. |
| Identify a set of components that demonstrate patterns of efficacy for weight loss | 12 and 24 weeks | Determine the change in weight as measured by digital scale. A lower weight indicates an improvement. |
| Identify a set of components that demonstrate patterns of efficacy for improvement in body composition | 12 and 24 weeks | Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement. |
| Measure the change in systolic blood pressure to determine improved cardiometabolic health | 12 and 24 weeks | Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement. |
| Measure the change in diastolic blood pressure to determine improved cardiometabolic health | 12 and 24 weeks | Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement. |
| Measure changes in total cholesterol to determine improved cardiometabolic health | 12 and 24 weeks | Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement. |
| Measure changes in LDL cholesterol to determine improved cardiometabolic health | 12 and 24 weeks | LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement. |
| Measure changes in HDL cholesterol to determine improved cardiometabolic health | 12 and 24 weeks | HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement. |
| Measure changes in triglycerides to determine improved cardiometabolic health | 12 and 24 weeks | Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement. |
| Measure changes in glucose to determine improved cardiometabolic health | 12 and 24 weeks | Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement. |
| Measure changes in insulin to determine improved cardiometabolic health | 12 and 24 weeks | Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement. |
| Intervention safety determined by number of adverse events | 12 and 24 weeks | Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily B Hill, PhD, RDN
University of Colorado, Denver
Outcome results
None listed