Cancer Survivorship, Obesity, Overweight
Conditions
Brief summary
This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell).
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 + BfitBwell 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 12-week single-arm study of the integrated BfedBwell + BfitBwell 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 evaluate proof-of-concept prior to advancing to efficacy testing.
Interventions
BEHAVIORALGroup-based education and discussion
Group-based education and discussion (60 minutes each per week, virtual and in-person) based upon guidelines for nutrition for cancer survivorship (e.g., follow a plant-based diet with a variety of vegetables, fruits, whole grains, and legumes; limit alcohol intake; reduce consumption of highly processed foods and foods high in salt; achieve a weekly calorie deficit of approximately 3500 kcal for weight loss)
BEHAVIORALIndividual 1:1 counseling
Individual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers
BEHAVIORALGroup based behavioral skills development and cooking demonstrations
Group-based behavioral skills development sessions and cooking demonstrations (60-90 minutes each per month, in-person) to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading).
BEHAVIORALBfitBwell
This program consists of a supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. Body Mass Index 25-45 kg/m2 4. Completion of active cancer therapy with curative intent at least three months and no more than five years prior to enrollment; ongoing hormone therapy is permitted 5. 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 6. 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 guidelines (note: any positive responses will trigger a required physician clearance form) 7. Speak English 8. Have access to a computer or smart phone and Internet 9. Live or work within 30 miles of the Anschutz Health and Wellness Center (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects) 10. Not be planning to travel for \>2 consecutive weeks or relocate/move during the intervention 11. Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study 12. Capable and willing to give informed consent and understand
Exclusion criteria
13. Willing to attend weekly small group sessions (behavioral skills development and/or group support) and/or 1:1 counseling held by a registered dietitian (RD) and attend up to two BfitBwell exercise sessions per week 14. Not meeting dietary guidelines \[i.e., Healthy Eating Index (HEI) score \<80 as assessed via National Cancer Institute Diet History Questionnaire III (NCI DHQ III) food frequency questionnaire\] 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 | 12 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 | 12 weeks | Adherence will be assessed as \[# sessions attended/# sessions provided\] |
| Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention | 12 weeks | Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]. |
| Determine the research protocol retention feasibility of the BfedBwell nutrition intervention | 12 weeks | Retention will be assessed as \[# of participants who complete the 12-week intervention/# of participants enrolled\]. |
| Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM) | 12 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 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 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 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. |
| Determine the intervention acceptability by participants and program providers during qualitative interviews | 12 weeks | 1:1 interviews will be conducted with all program delivery staff and BfedBwell survivorship nutrition intervention participants after the 12-week intervention to assess acceptability of intervention and provide feedback for continued refinement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess preliminary efficacy for increased adherence to lifestyle recommendations | 12 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. |
| Assess preliminary efficacy for weight loss | 12 weeks | Determine the change in weight as measured by digital scale. A lower weight indicates an improvement. |
| Assess preliminary efficacy for improvement in body composition | 12 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 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 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 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 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 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 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 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 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 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