120 Participants NeededMy employer runs this trial

Personalized Exercise Program for Breast Cancer

(STEPS-BC Trial)

Recruiting at 1 trial location
KC
Overseen ByKaren Craver, MT, MHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
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 explores how a personalized exercise program and health education can help breast cancer patients maintain fitness, heart health, and quality of life during chemotherapy. Participants will either join virtual health workshops (Healthy Living Intervention) or combine them with personalized virtual exercise sessions (Physical Activity Intervention). The trial seeks individuals with stage I-III breast cancer who are about to start chemotherapy and can walk at least two blocks without major issues like chest pain or shortness of breath. Participation may help patients better understand how to lead a healthy lifestyle during treatment. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance quality of life during chemotherapy.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have shown that exercise programs are safe for people with breast cancer. Research suggests these programs are easy to follow and enhance quality of life, even for those with advanced cancer. For example, a review of studies found that participants often adhere to these programs. Another study noted that exercise is generally safe for breast cancer survivors.

Similarly, healthy living programs, which include advice on diet and lifestyle, have also proven safe. Studies show that adopting a healthy lifestyle can lower the risk of cancer recurrence and improve survival rates. For instance, research indicates that women with high healthy lifestyle scores had a significantly lower risk of cancer.

Both exercise and healthy living programs have demonstrated safety in studies, making them good options for breast cancer patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Personalized Exercise Program for Breast Cancer because it offers a new way to support patients during chemotherapy. Unlike traditional treatments that focus solely on medication, this program emphasizes staying active and healthy living to potentially improve outcomes. The Physical Activity Intervention arm provides personalized exercise sessions and tools like a Fitbit and resistance bands, helping patients stay engaged and active. Meanwhile, the Healthy Living Intervention arm focuses on organized health workshops, which aim to educate and empower patients to make healthy lifestyle choices. By combining exercise with education, this trial explores how lifestyle changes can complement standard cancer treatments, potentially enhancing overall well-being and treatment effectiveness.

What evidence suggests that this trial's interventions could be effective for breast cancer patients undergoing chemotherapy?

Research has shown that physical activity benefits breast cancer patients by helping them live longer and improving their overall quality of life. Breast cancer survivors who exercise regularly often feel healthier and experience fewer treatment-related symptoms. In this trial, participants in Arm 1 will receive a Physical Activity Intervention (PAI) combined with a Healthy Living Intervention (HLI), which includes personalized exercise sessions and health workshops.

Participants in Arm 2 will receive only the Healthy Living Intervention (HLI), focusing on organized health workshops. Making healthy lifestyle changes can lead to better outcomes, reducing the chance of cancer recurrence and helping maintain a healthy weight. Although the best approach remains unclear, living a healthy lifestyle generally supports better health during and after treatment.34567

Who Is on the Research Team?

GL

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with stage I-III breast cancer (not metastatic) who are about to start chemotherapy. Participants must be able to use a stationary bike, walk two blocks without major symptoms, read English, and have access to teleconferencing or join a tablet lending program.

Inclusion Criteria

Must be able to read and understand English
I am between 18 and 85 years old.
I have stage I-III breast cancer, not metastatic, and am being treated to cure it.
See 8 more

Exclusion Criteria

Plans to relocate within 6 months of enrollment and unable to participate in study procedures
May not be on simultaneous interventional supportive care (non-therapeutic) clinical trial
I have not had a heart attack in the past 28 days.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Chemotherapy

Participants attend virtual pre-chemotherapy exercise sessions and health workshops

3 weeks
2 virtual exercise sessions, 1 virtual health workshop

Chemotherapy and Intervention

Participants receive chemotherapy and attend virtual personalized exercise sessions and health workshops

24 weeks
Weekly to bi-weekly virtual sessions

Follow-up

Participants are monitored for changes in VO2, LVEF, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Healthy Living Intervention (HLI)
  • Physical Activity Intervention (PAI)

Trial Overview

The study compares virtual healthy living education alone versus the same education plus personalized exercise sessions. Both aim to help breast cancer patients maintain fitness, heart health, and quality of life during chemotherapy. Participation includes online classes and supervised exercise.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (PAI+HLI)Experimental Treatment9 Interventions
Group II: Arm 2 (HLI)Active Control8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Review article The effects of lifestyle and behavioural ...

Lifestyle/behavioural interventions may improve breast cancer outcomes and quality of life (QoL); however, uncertainty remains about the most effective ...

outcomes from the Healthy Living after Cancer ... - PMC - NIH

As with the main evaluation, these showed all outcomes tended towards improvement in every Cancer Council (not always statistically significant), and with some ...

NCT00003787 | Women's Healthy Eating and Living Study

Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables, fruit, and fiber and low in fat.

Lifestyle Interventions Are Associated With Reduced ...

Specifically, the risk of breast cancer recurrence was 76% (HR 0.24, 95% CI [0.06, 0.95]) lower for women with HR-positive breast cancer who ...

Healthy lifestyles, screening, and breast cancer mortality in ...

Healthy lifestyles and screening are the two major interventions to prevent breast cancer mortality. However, their effects have not been compared ...

Healthy Lifestyle Index and Breast Cancer Risk among ...

A 5% risk reduction per point increase in the HLI score was observed overall with comparable 3% to 5% risk reductions across racial and ethnic groups (P = 0.001 ...

Influence of healthy lifestyle on the incidence and survival of ...

Compared to the low HLI group, participants with a high HLI had a significantly lower risk of cancer (HR = 0.92, 95% CI 0.90–0.94) and cancer- ...