Weight Loss Program for Breast Cancer Survivors

Overseen By Nia S Mitchell, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Weight loss medications

Disqualifiers: Type II Diabetes, other weight loss programs, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance a weight loss program for women who have survived breast cancer. It incorporates input from these survivors to customize the Take Off Pounds Sensibly (TOPS) program to meet their specific needs. Suitable participants are women who have had breast cancer and have a body mass index (BMI) of 25 or higher, typically classified as overweight. Participants should not have Type II Diabetes, should not be enrolled in another weight loss program, or taking weight loss medication, and must have access to a smartphone or the internet to attend meetings. This trial provides an opportunity to help shape a program that supports healthier living after cancer treatment. As an unphased trial, it offers a unique chance to contribute to developing a supportive weight loss program tailored for breast cancer survivors.

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 cannot participate if you are taking a weight loss medication.

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

Research has shown that weight loss programs for breast cancer survivors, such as Take Off Pounds Sensibly (TOPS), are safe. Studies found that participants experienced no serious side effects, suggesting the program is well-tolerated. The program emphasizes community support and encourages healthy weight loss. Overall, it seems to be a safe choice for those wanting to manage their weight after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Take Off Pounds Sensibly (TOPS) weight loss program for breast cancer survivors because it offers a supportive, community-based approach to weight management. Unlike many weight loss treatments that rely on medications or intensive one-on-one counseling, TOPS incorporates group meetings and peer support to encourage sustainable lifestyle changes. This approach can be particularly beneficial for breast cancer survivors who often need social support to navigate their unique health challenges. By fostering a sense of community and accountability, TOPS aims to provide a more holistic and empowering path to achieving healthy weight loss.

What evidence suggests that the TOPS program is effective for weight loss in breast cancer survivors?

Research has shown that the Take Off Pounds Sensibly (TOPS) program, which participants in this trial will attend, can help breast cancer survivors lose weight. Studies have found that it leads to better eating habits, increased physical activity, and improvements in health markers related to inflammation and insulin, which are important for overall health. One study found that participants who stayed with TOPS for several years maintained their weight loss over time. This suggests that TOPS could be a useful tool for managing weight and improving health in breast cancer survivors. ^{3 6 7 8 9}

Who Is on the Research Team?

Nia S Mitchell, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for African American women who have survived breast cancer. It aims to adapt a weight loss program called TOPS to better suit their needs. Participants will review materials and provide feedback to help tailor the program.

Inclusion Criteria

I am an African American woman with breast cancer, a BMI of 25 or higher, and have finished my initial cancer treatments.

Exclusion Criteria

Those participating in another weight loss program

My cancer doctor does not approve of me joining a weight loss program.

Those without smart phones or internet connections or the ability to attend meetings via Zoom

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group Feedback

Participants provide feedback on TOPS materials through focus groups conducted via Zoom

1-2 weeks

1-2 virtual meetings

Tailored TOPS Classes

Participants attend dietician-led TOPS sessions virtually for weight loss and heart health improvement

6 months

Weekly virtual sessions

Community TOPS Classes

Participants join a local TOPS chapter for continued weight loss support

6 months

Weekly in-person sessions

Follow-up

Participants are monitored for weight and heart health improvements

12 months

Blood draws at baseline, 3, 6, and 12 months; surveys via email

What Are the Treatments Tested in This Trial?

Interventions

• Take Off Pounds Sensibly (TOPS)

Trial Overview The intervention being tested is the Take Off Pounds Sensibly (TOPS) classes, which are community-led weight loss programs. The study seeks to modify these classes based on feedback from focus groups of African American breast cancer survivors.

How Is the Trial Designed?

Group I: TOPS Classes Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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 6-month LEAN Self-Guided lifestyle intervention resulted in a significant average weight loss of 1.3 kg for breast cancer survivors compared to a waitlist group, indicating its efficacy in promoting healthy weight management.

This low-resource intervention, which utilized printed materials and online videos, also showed potential improvements in physical activity, diet quality, and fatigue, suggesting it could be effectively integrated into various healthcare settings for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors. Puklin, LS., Harrigan, M., Cartmel, B., et al.[2023]

A systematic review of 14 trials involving weight loss interventions for women with breast cancer found that significant weight loss (≥5%) was achieved in several studies, indicating that weight management is feasible for this population.

The interventions were deemed safe, with no serious adverse events reported, suggesting that behaviorally based weight loss strategies can be safely implemented in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss intervention trials in women with breast cancer: a systematic review. Reeves, MM., Terranova, CO., Eakin, EG., et al.[2022]

A 24-week lifestyle intervention based on the Diabetes Prevention Program led to an average weight loss of 3.8 kg among 14 early-stage breast cancer survivors, indicating its efficacy in promoting weight loss in this population.

Participants who lost more than 7% of their body weight were older and more engaged in the program, suggesting that attendance and age may influence the success of lifestyle interventions for weight management in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention on body weight and serum biomarkers in breast cancer survivors with overweight and obesity. Campbell, KL., Van Patten, CL., Neil, SE., et al.[2018]

In a pilot study of 48 obese breast cancer survivors over 24 months, those with psychiatric disorders lost significantly less weight (1.2% at 30 months) compared to those without such disorders (7.8% weight loss), indicating that mental health can impact weight loss efforts.

The study highlights the importance of recognizing and treating psychiatric disorders in cancer survivors, as these conditions may hinder successful weight management and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of psychiatric diagnosis and weight loss maintenance in obese breast cancer survivors. Jenkins, I., Djuric, Z., Darga, L., et al.[2007]

The ENERGY study is a 4-year clinical trial involving 693 overweight or obese women with early-stage breast cancer, aimed at demonstrating the feasibility of sustained weight loss and its impact on quality of life and co-morbidities.

The trial's intervention includes a cognitive-behavioral weight loss program, which could establish weight loss support as a new standard of care for breast cancer survivors, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. Rock, CL., Byers, TE., Colditz, GA., et al.[2021]

A 12-month weight loss intervention for breast cancer survivors resulted in significant reductions in weight, fat mass, and metabolic syndrome risk factors, demonstrating its efficacy in improving health outcomes post-cancer treatment.

Participants in the intervention also reported better physical quality of life, reduced musculoskeletal pain, and improved body image, with these benefits largely maintained at 18 months, although some lean mass loss was noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial. Reeves, MM., Terranova, CO., Winkler, EAH., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5562172/

Efficacy of a Weight Loss Intervention for African American ... Weight loss intervention trials with breast cancer survivors report improvements in diet and physical activity, biomarkers of inflammation and insulin ...

2. withpower.com withpower.com/trial/phase-breast-neoplasms-11-2024-889b7

Weight Loss Program for Breast Cancer Survivors The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06658912

Planning Grant for TOPS for Breast Cancer Survivors The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379715000756

Research Article Up to 7 Years of Sustained Weight Loss ... The purpose of this study is to determine the long-term weight loss of participants who consecutively renew their annual membership in Take Off Pounds Sensibly ...

5. ctv.veeva.com ctv.veeva.com/study/tops-for-african-american-breast-cancer-survivors

TOPS for African American Breast Cancer Survivors Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06658912

Planning Grant for TOPS for Breast Cancer Survivors The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04741802

TOPS for African American Breast Cancer Survivors Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8605026/

The Impact of Weight Loss on Physical Function and ... Our results support research suggesting that weight loss may be key to enhancing quality of life, particularly PF, in breast cancer survivors who are overweight ...

9. researchgate.net researchgate.net/publication/46414231_Determining_the_Effectiveness_of_Take_Off_Pounds_Sensibly_TOPS_a_Nationally_Available_Nonprofit_Weight_Loss_Program

Determining the Effectiveness of Take Off Pounds Sensibly ... Individuals with consecutive renewals in TOPS lost 5.9-7.1% of their initial weight over a period of 1-3 years. People who remained in the ...