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

25 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Take Off Pounds Sensibly (TOPS) for weight loss in breast cancer survivors?

Research shows that weight loss programs for breast cancer survivors, which include diet, physical activity, and behavior changes, can lead to significant weight loss. These programs have been found to be safe and feasible, with many studies reporting meaningful weight loss of 5% or more. ^{1 2 3 4 5}

Is the weight loss program for breast cancer survivors safe?

The weight loss programs reviewed for breast cancer survivors have been found to be safe, with no serious adverse events reported in the studies. ^{1 2 6 7 8}

How does this weight loss treatment for breast cancer survivors differ from other treatments?

This weight loss treatment is unique because it is a lifestyle intervention specifically designed for breast cancer survivors, modeled on the Diabetes Prevention Program, and includes group-based diet sessions and regular exercise. Unlike other treatments, it focuses on a holistic approach to weight management, addressing the unmet need for effective programs in this population. ^{4 6 9 10 11}

What is the purpose of this trial?

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 African American breast cancer survivors. This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of African American women who are breast cancer survivors. The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for African American breast cancer survivors. This ClinicalTrials.gov record is specific to the second part of the study.

Research Team

Nia S Mitchell, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Weight loss intervention trials in women with breast cancer: a systematic review. [2022]

2. 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]

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

Weight Loss Intervention for Breast Cancer Survivors: A Systematic Review. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Design and methods of a translational, community-based, lifestyle weight management pilot intervention trial in breast cancer survivors with overweight or obesity. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Weight gain and recovery of pre-cancer weight after breast cancer treatments: evidence from the women's healthy eating and living (WHEL) study. [2022]

6. Switzerland 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. [2023]

7. United States 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial. [2021]

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

Feasibility of a lifestyle intervention on body weight and serum biomarkers in breast cancer survivors with overweight and obesity. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. [2021]

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

Relationship of psychiatric diagnosis and weight loss maintenance in obese breast cancer survivors. [2007]