BfedBwell Program for Cancer Survivorship

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Overseen ByMelissa Mamele, MS, RD, CSCS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a lifestyle program for cancer survivors, focusing on nutrition, exercise, sleep, and stress management. Participants receive personalized nutrition advice, exercise plans, and use wearables to track their progress. The program suits individuals who have had cancer in the last 10 years, completed active treatment, and are ready to join a structured lifestyle program. Participants must also attend meetings and have internet access for virtual sessions. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance the quality of life for cancer survivors.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must refrain from using nutritional supplements unless prescribed by a doctor, and certain medications that affect appetite, weight, or energy metabolism are not allowed. It's best to discuss your specific medications with the trial team.

What prior data suggests that this program is safe for cancer survivors?

Research has shown that lifestyle programs like the BfedBwell INSPIRE Pilot are generally safe and easy to follow. In previous studies, similar programs have produced positive results. For instance, in a weight loss program for breast cancer survivors, participants lost an average of 4.7% of their starting weight, demonstrating the program's effectiveness and safety.

Another study involving women with advanced breast cancer found that lifestyle changes provided benefits and participants could adhere to the program. There were no major reports of serious side effects, indicating that most participants did not experience harmful effects.

These findings suggest that the BfedBwell INSPIRE Pilot, which includes nutrition and exercise support along with technology to track health habits, is likely safe for participants. It is important to consult a healthcare provider to determine if this program is suitable.12345

Why are researchers excited about this trial?

Researchers are excited about the BfedBwell INSPIRE Intervention because it offers a holistic approach to cancer survivorship, combining nutrition education with structured exercise. Unlike traditional treatments that might focus solely on medication or surgery, this program emphasizes lifestyle changes that empower participants to actively manage their health. Key features include personalized nutrition counseling, behavioral skills training, and the use of wearable technology to monitor activity, sleep, and weight. This comprehensive package aims to improve overall well-being and potentially reduce the risk of cancer recurrence, offering a fresh perspective beyond conventional care.

What evidence suggests that the BfedBwell INSPIRE Pilot is effective for cancer survivorship?

Studies have shown that lifestyle programs like BfedBwell can benefit cancer survivors. In a previous trial, breast cancer patients who joined a remote weight loss program lost about 4.7% of their starting weight, improving their overall health. Research also indicates that similar programs can enhance quality of life and increase physical activity and strength. In this trial, participants will receive the BfedBwell INSPIRE Intervention, which includes lessons on healthy eating and exercise, personalized advice, and support from wearable devices. These elements help survivors manage their health better and may lead to positive changes in important health indicators.12345

Who Is on the Research Team?

EH

Emily Hill, PhD, RDN

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have had cancer in the past 10 years, finished main cancer treatments at least 3 months ago, have a BMI between 25 and 45, can safely join an exercise program, speak English, live or work near the study site, and have access to internet and a smart device.

Inclusion Criteria

I finished active cancer treatment 3 months to 10 years ago or am on long-term maintenance therapy.
* 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)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming.

24 weeks
Weekly sessions

Follow-up

Participants are monitored for changes in sleep quality, perceived stress, and physiological indicators of stress and immune function.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BfedBwell INSPIRE Pilot

Trial Overview

The study tests a lifestyle program combining nutrition education (with group support and one-on-one counseling), behavioral skills training, wearable tech for tracking health habits, and supervised exercise. It aims to see if this approach helps cancer survivors improve their health.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BfedBwell INSPIRE InterventionExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

American Institute for Cancer Research

Collaborator

Trials
12
Recruited
8,600+

Citations

Study Details | NCT07446595 | BfedBwell INSPIRE Pilot

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, ...

NCT06191666 | BfedBwell Proof-of-Concept Pilot

This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an ...

Weight Loss Trial Reports Success for Breast Cancer ...

Breast cancer patients who participated in a remote weight loss intervention program lost an average of 4.7 percent of their baseline body ...

BfedBwell Program for Cancer Survivorship

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention ...

A lifestyle program for women metastatic breast cancer

Our results show clinically meaningful improvements in QOL, increased physical activity and strength. We also find improved trends in biomarkers of prognosis, ...