Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.

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)

Group-based education and discussion

Individual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers

Individual 1:1 counseling

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).

Group based behavioral skills development and cooking demonstrations

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.

BfitBwell

Claudia Schaefer

Emily B Hill, PhD, RDN

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).

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.

BfedBwell Proof-of-Concept Pilot

Design and Integration of a Survivorship Nutrition Intervention Into an Established Exercise Oncology Program: the BfedBwell Pilot Intervention

Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll.

Adherence will be assessed as \[# sessions attended/# sessions provided\]

Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\].

Retention will be assessed as \[# of participants who complete the 12-week intervention/# of participants enrolled\].

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.

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.

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.

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.

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.

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.

Determine the change in weight as measured by digital scale. A lower weight indicates an improvement.

Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement.

Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement.

Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement.

Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement.

LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement.

HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement.

Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement.

Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement.

Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement.

Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff.

Spots Global Cancer Trial Database for bfitbwell

Every month we try and update this database with for bfitbwell cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bfitbwell

Every month we try and update this database with for bfitbwell cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bfitbwell cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.