Mobile-Health Lifestyle Interventions for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Lorezo Cohen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Recurrent BCa, Other cancer, Thought disorders, Diabetes, Mobility issues, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 38 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping women with breast cancer improve their quality of life through a lifestyle program. It aims to enhance diet, exercise, stress management, and overall well-being using education and support tools like FitBits and counseling. Participants will either join a group with a structured lifestyle program (behavioral intervention) or receive standard care. Women who have completed their main cancer treatments, have a BMI of 25 or higher, and face challenges with diet, exercise, or stress management may be suitable candidates. The trial takes place at the University of Texas MD Anderson or Wake Forest locations. As an unphased trial, it provides a unique opportunity to enhance lifestyle and well-being with expert support.

Will I have to stop taking my current medications?

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

What prior data suggests that this lifestyle program is safe for breast cancer patients?

Research shows that lifestyle and behavior changes for breast cancer patients are generally safe and manageable. Studies indicate that these changes can lead to better eating habits and increased physical activity without major side effects. Participants in these programs often experience benefits such as weight loss and improved overall health.

Reports of serious negative effects from these changes are absent. In fact, they are often seen as a positive addition to regular cancer treatment. Participants typically find them helpful for enhancing their quality of life and making healthier choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for breast cancer because they focus on empowering patients to take an active role in their health through behavior and lifestyle changes. Unlike standard treatments such as surgery, chemotherapy, and radiation, these interventions include personalized nutrition education and structured physical activity with tools like FitBit for real-time tracking. This approach targets the overall well-being of patients, potentially improving their quality of life and complementing existing medical treatments. By integrating aerobic exercises and resistance training, the program aims to enhance physical fitness and possibly reduce cancer-related fatigue, offering a holistic strategy that goes beyond traditional care.

What evidence suggests that these lifestyle interventions could be effective for breast cancer?

Research has shown that lifestyle and behavior changes can greatly benefit breast cancer patients. Studies have found that these changes can reduce the risk of cancer recurrence and enhance patients' quality of life. For instance, increasing exercise and learning about healthy eating can lead to better health outcomes. In this trial, participants in Group I (CLIP) will engage in a mobile health program that includes nutrition education and behavioral intervention, which increased activity levels after three months in previous research. Another study demonstrated that cognitive-behavioral therapy (CBT) can also improve health for these patients. Overall, these methods hold promise for helping breast cancer survivors live healthier lives. ^{1 6 7 8 9}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with stage I-III breast cancer who've finished chemotherapy and surgery. They should have a BMI of 25 or higher, engage in little physical activity, eat less than three servings of fruits and vegetables daily, and not practice stress management often. Participants must be able to read English, use the internet, perform light exercise (with medical clearance if needed), and visit certain locations for blood collection.

Inclusion Criteria

This criterion means that participants need to have at least two of the listed lifestyle factors at the time of their diagnosis.

You have a body mass index (BMI) of 25 or more.

You eat fewer than 3 servings of fruits and vegetables each day.

Exclusion Criteria

Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)

I cannot get in and out of a chair without help.

You have a serious mental illness like schizophrenia or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention for 26 weeks, including physical activity with a FitBit

38 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Intervention
• Lifestyle Interventions

Trial Overview

The study tests a lifestyle program designed to improve diet, increase physical activity using FitBit trackers, teach stress management through mindfulness practices, enhance sleep hygiene techniques, provide behavioral counseling and social support. The goal is to see if this program can boost quality of life for breast cancer survivors.

How Is the Trial Designed?

Group I: GROUP I (CLIP) Experimental Treatment 5 Interventions

Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).

Group II: GROUP II (usual care) Active Control 2 Interventions

Patients have access to all usual care supportive services.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

A randomized controlled trial involving 80 women with breast cancer showed that a 24-week lifestyle intervention program, including dietary training and aerobic exercises, significantly reduced fatigue and body mass index (BMI) while improving quality of life (QoL) and sleep quality compared to a control group.

The results suggest that lifestyle interventions can serve as an effective non-pharmacologic therapy to help manage physical and psychological symptoms in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Lifestyle Interventions in Breast Cancer Women after Completion of Primary Therapy: A Randomized Study. Ghavami, H., Akyolcu, N.[2022]

Lifestyle interventions that include nutrition education, physical activity, and stress management can significantly improve the overall health of breast cancer patients.

Implementing a structured lifestyle intervention program is essential for enhancing the well-being of individuals undergoing treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. Hwang, ES., Nho, JH.[2020]

Out of 302 breast cancer apps identified, only 30 (9.9%) effectively supported behavior change, primarily focusing on early detection rather than comprehensive cancer care management.

Apps with star ratings were found to include significantly more behavior change techniques, highlighting a potential link between user ratings and the effectiveness of the app's design in promoting health behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Evidence-Based Best Practices and Behavior Change Techniques in Breast Cancer Apps: Systematic Analysis. Kalke, K., Ginossar, T., Bentley, JM., et al.[2021]

This study will compare the effectiveness of a mobile health application combined with face-to-face rehabilitation versus the app alone in improving the Quality of Life for breast cancer survivors, involving women aged 25 to 75 with specific health criteria.

The primary outcome will be assessed after 8 weeks, focusing on Quality of Life, while secondary outcomes will include body composition, functionality, cognitive function, and mental health, highlighting the importance of both technology and professional support in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. Lozano-Lozano, M., Martín-Martín, L., Galiano-Castillo, N., et al.[2022]

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]

A systematic review of 29 randomized controlled trials found that 17 were effective in reducing cancer-related fatigue among survivors, with key behavior change techniques (BCTs) like goal setting and instruction on how to perform behaviors being frequently used.

The BCT 'Generalisation of the target behaviour' was identified as promising for helping cancer survivors incorporate lifestyle changes into their daily lives, but there is a need for more studies focusing on dietary behaviors and including follow-up assessments to evaluate long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques used in lifestyle interventions that aim to reduce cancer-related fatigue in cancer survivors: a systematic review. de Vries-Ten Have, J., Winkels, RM., Kampman, E., et al.[2023]

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