BfedBwell Program for Cancer Survivors

Overseen By Claudia Schaefer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Appetite suppressants, Antipsychotics, Tricyclic antidepressants, others

Disqualifiers: Diabetes, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

74 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must agree to refrain from using all nutritional supplements unless prescribed by a doctor. If you are on medications that significantly impact appetite, weight, or energy metabolism, you may not be eligible to participate.

What data supports the effectiveness of the BfedBwell treatment for cancer survivors?

Research shows that nutrition education and counseling can improve dietary habits and physical function in cancer survivors, as seen in studies like the NutriCare program and the HEAL-BCa study, which reported positive impacts on diet and nutrition literacy. ^{1 2 3 4 5}

Is the BfedBwell Program for Cancer Survivors safe for humans?

The available research suggests that nutrition and weight loss interventions for cancer survivors, like those in the BfedBwell Program, are generally safe and acceptable for participants. These studies have shown that such programs can be feasibly delivered and may provide benefits without significant safety concerns. ^{1 4 6 7 8}

What makes the BfedBwell Program for Cancer Survivors unique compared to other treatments?

The BfedBwell Program is unique because it combines personalized counseling, behavioral skills training, a core curriculum, and group support to help cancer survivors improve their nutrition and lifestyle. This comprehensive approach is designed to address the specific dietary and behavioral needs of cancer survivors, which can help manage weight and improve overall health outcomes. ^{1 9 10 11 12}

Research Team

Emily B Hill, PhD, RDN

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for cancer survivors. Participants should be interested in a clinical exercise oncology program and willing to engage with nutrition education, personal counseling, skill development, and group support.

Inclusion Criteria

For intervention participants: Men and women, Age 18-75 years, BMI 25-45 kg/m2, 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, 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 guidelines (note: any positive responses will trigger a required physician clearance form), Speak English, Have access to a computer or smart phone and Internet, 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 to travel for >2 consecutive weeks or relocate/move during the intervention, Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study, Capable and willing to give informed consent and understand exclusion criteria, 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, 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]

I am over 18, speak English, and have experience in delivering health programs.

Exclusion Criteria

For program delivery staff: None

For intervention participants: Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher, Actively undergoing cancer therapy or within 3 months of completion of surgery, chemotherapy, or radiation treatment, Greater than 5 years post-active therapy, Plans to relocate within the next 6 months, Plans for extended travel (>2 weeks) within the next 6 months, For females: Currently pregnant or lactating, Pregnant within the past 6 months, 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, Any major surgery within the past 3 months, including mastectomy, Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon), Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism, Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope), Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHg, systolic blood pressure >160 mmHg, or resting heart rate >100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months), Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c >7.5%, or fasting glucose ≥126 mg/dL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin alone, History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable, Triglycerides >500 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months), LDL cholesterol >200 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months), Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease, Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months, Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents, Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency, Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed >1 year before screening, (2) lap banding if the band has been removed >1 year before screening, (3) intragastric balloon if the balloon has been removed >1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed >1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed >1 year before screening, Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months, Previous participation the BfitBwell exercise oncology program, Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility), History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the study MD to determine if it is appropriate for the subject to participate in the study, Current severe depression or history of severe depression within the previous year, based on Center for Epidemiologic Studies Depression Scale (CES-D), History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions, Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on ACSM guidelines, Are cognitively unable to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BfedBwell intervention, which includes core curriculum, 1:1 counseling, behavioral skills, and group support over a 6-month period

24 weeks

Regular visits as per intervention components

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiometabolic health and adherence to guidelines

4 weeks

Treatment Details

Interventions

• BfedBwell - 1:1 Counseling
• BfedBwell - Behavioral Skills
• BfedBwell - Core Curriculum
• BfedBwell - Group Support
• Program delivery

Trial Overview The BfedBwell Optimization Pilot tests three components: personalized dietary counseling by a dietitian, learning behavioral skills, and participating in group support sessions—all alongside a core nutrition curriculum within an exercise program for cancer survivors.

Participant Groups

Group I: Program Provider Experimental Treatment 1 Intervention

Providers will deliver and evaluate one or more components of the diet or exercise interventions

Group II: Core Curriculum,1:1 Counseling, and Group Support Experimental Treatment 3 Interventions

Participants will receive core curriculum, 1:1 counseling, and group support

Group III: Core Curriculum, Behavioral Skills, and Group Support Experimental Treatment 3 Interventions

Participants will receive core curriculum, behavioral skills, and group support

Group IV: Core Curriculum, 1:1 Counseling, and Behavioral Skills Experimental Treatment 3 Interventions

Participants will receive core curriculum, 1:1 counseling, and behavioral skills

Group V: Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support Experimental Treatment 4 Interventions

Participants will receive core curriculum, 1:1 counseling, behavioral skills, and group support

Group VI: Core Curriculum and Group Support Experimental Treatment 2 Interventions

Participants will receive core curriculum and group support

Group VII: Core Curriculum and Behavioral Skills Experimental Treatment 2 Interventions

Participants will receive core curriculum and behavioral skills

Group VIII: Core Curriculum and 1:1 Counseling Experimental Treatment 2 Interventions

Participants will receive core curriculum and 1:1 counseling

Group IX: Core Curriculum Experimental Treatment 1 Intervention

Participants will receive core curriculum

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Cancer patients and survivors often face poor nutritional intake, which can lead to malnutrition, loss of lean body mass, and excessive weight loss during and after treatment, negatively impacting their clinical outcomes.

Obesity is common among cancer patients and can mask malnutrition, posing additional risks for cancer recurrence and survival; thus, effective nutritional education and targeted lifestyle interventions are crucial for improving adherence to dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. Greenlee, H., Santiago-Torres, M., McMillen, KK., et al.[2020]

A cluster-randomized clinical trial involving 468 cancer patients receiving radiotherapy showed that an evidence-based nutrition education and counseling (NEC) program significantly improved nutrition status, as indicated by lower PG-SGA scores (5.6 vs 6.9) and reduced malnutrition rates (56.0% vs 70.5%) compared to usual care.

The study demonstrates that implementing NEC in clinical settings can effectively reduce malnutrition among cancer patients undergoing treatment, highlighting its potential as a standard practice in radiotherapy units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. Zhang, Z., Zhu, Y., Zhang, L., et al.[2022]

The NutriCare nutrition education program was successfully integrated into outpatient oncology care for 20 breast cancer survivors, with a high completion rate of 90% and positive feedback from participants regarding its feasibility and impact on their diet.

Participants showed a significant improvement in physical function after six weeks, indicating that nutrition education can have beneficial effects on health outcomes for cancer survivors, although no significant changes in overall quality of life or dietary quality were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Nutrition into Outpatient Oncology Care-A Pilot Trial of the NutriCare Program. Keaver, L., Yiannakou, I., Zhang, FF.[2021]

A pilot study involving 59 breast cancer survivors showed that nutrition education workshops were well-received and feasible, with high follow-up rates of 89% in the control group and 77% in the intervention group.

While the workshops did not significantly improve nutrition literacy scores at the 3-month follow-up, participants valued the social support and expressed a desire for more tailored dietary information, indicating potential for future interventions to enhance dietary knowledge among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial. Parekh, N., Jiang, J., Buchan, M., et al.[2022]

The Eating As Treatment (EAT) program, which trains dietitians to use psychological techniques, significantly improved nutritional status in head and neck cancer patients undergoing radiation therapy, as evidenced by better scores on the Patient-Generated Subjective Global Assessment at the end of treatment.

Patients receiving the EAT intervention experienced not only improved nutrition but also a higher likelihood of being well-nourished, less weight loss, fewer treatment interruptions, lower depression scores, and a better quality of life compared to those receiving standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Britton, B., Baker, AL., Wolfenden, L., et al.[2019]

In a pilot study involving 14 overweight breast cancer survivors, participants completed a 10-week online intervention that led to an average weight loss of 2.83% and significant improvements in physical activity, intuitive eating habits, and self-efficacy regarding healthy choices.

Despite modest weight loss, the intervention resulted in meaningful psychosocial benefits, including improved body image, increased self-compassion, and empowerment, highlighting the importance of addressing both physical and emotional health in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Weighing' Losses and Gains: Evaluation of the Healthy Lifestyle Modification After Breast Cancer Pilot Program. Male, D., Fergus, K., Yufe, S.[2023]

A telephone-delivered weight loss intervention for women with a BMI of 25-40 kg/m2 after breast cancer treatment resulted in a significant average weight loss of 3.1 kg compared to usual care, demonstrating its efficacy.

The intervention was found to be feasible and acceptable, with high participant satisfaction, and only one reported adverse event, indicating it is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. Reeves, M., Winkler, E., Mccarthy, N., et al.[2022]

The Living Well after Breast Cancer trial is evaluating a 12-month telephone-delivered weight loss intervention for women with stage I-III breast cancer, aiming to assess its impact on weight change and various health outcomes in 156 participants.

This study will not only measure weight loss but also examine improvements in body composition, quality of life, and chronic disease risk, providing crucial data for integrating weight management into routine care for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer. Reeves, MM., Terranova, CO., Erickson, JM., et al.[2019]

This systematic review analyzed 11 randomized controlled trials (RCTs) focused on theory-based lifestyle interventions for weight loss in breast cancer survivors, finding that 7 of these trials were classified as 'very promising' in their effectiveness to reduce body weight by at least 5%.

The most commonly used theoretical framework was Social Cognitive Theory, and all interventions included key behavioral change techniques such as goal setting and self-monitoring, which are crucial for successful weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Perperidi, M., Saliari, D., Christakis, C., et al.[2023]

Web-based nutritional counseling has been shown to effectively improve dietary intake, weight management, and quality of life for cancer patients and survivors, based on a systematic review of nine studies conducted across multiple countries.

The review highlights the potential of web-based methods to deliver accessible and affordable behavior change programs, emphasizing the need for further research on long-term outcomes and cost-effectiveness compared to traditional face-to-face counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based nutrition: a useful resource for cancer patients? Lazar, DE., Postolica, R., Hanganu, B., et al.[2023]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

Behavior change interventions can be feasible and effective in increasing fruit and vegetable consumption among cancer survivors, as shown in six studies with sample sizes ranging from 50 to 3088 participants.

While the interventions showed positive effects on fruit and vegetable intake, results for other dietary behaviors like wholegrain, processed meat, sugar, and alcohol consumption were inconsistent or not statistically significant, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effects of behavior change interventions for improving multiple dietary behaviors among cancer survivors: a systematic review. Gan, T., Cheng, HL., Tse, MMY.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Nutrition into Outpatient Oncology Care-A Pilot Trial of the NutriCare Program. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

'Weighing' Losses and Gains: Evaluation of the Healthy Lifestyle Modification After Breast Cancer Pilot Program. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Web-based nutrition: a useful resource for cancer patients? [2023]

11. England pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effects of behavior change interventions for improving multiple dietary behaviors among cancer survivors: a systematic review. [2022]