Mobile-Health Lifestyle Interventions for Breast Cancer

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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for breast cancer?

Research shows that lifestyle interventions, which include nutrition education, physical activity, and stress management, can improve the health and quality of life for breast cancer patients. These interventions help manage weight, enhance physical functioning, and reduce the risk of other health issues like diabetes and heart disease. ^{1 2 3 4 5}

Is the Mobile-Health Lifestyle Intervention generally safe for humans?

Lifestyle interventions, which include changes in diet, physical activity, and stress management, have been shown to improve health in breast cancer patients and survivors. These interventions are generally considered safe and can lead to benefits like better physical functioning and reduced risk of other health issues such as diabetes and heart disease. ^{1 2 4 6 7}

How is the Mobile-Health Lifestyle Intervention treatment for breast cancer different from other treatments?

This treatment is unique because it uses mobile health technology to promote lifestyle changes, such as increased physical activity, which can improve breast cancer survival and quality of life. Unlike traditional treatments, it focuses on behavioral changes through digital coaching and is tailored to the needs and preferences of breast cancer patients. ^{8 9 10 11 12}

What is the purpose of this trial?

This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

I am aware of who I am, where I am, and the current time.

Exclusion Criteria

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

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

You have a serious mental illness like schizophrenia or dementia.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. [2020]

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

Weight Management and Physical Activity for Breast Cancer Prevention and Control. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

[Interventions to improve healthy lifestyles and their effects on psychological variables among breast cancer survivors: a systematic review]. [2018]

4. Turkey pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Medical Oncologists' Perspectives on Prescribed Lifestyle Intervention-Experiences of Women with Breast Cancer and Providers. [2020]

6. Netherlands 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. [2023]

7. England 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. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Use of Evidence-Based Best Practices and Behavior Change Techniques in Breast Cancer Apps: Systematic Analysis. [2021]

9. England 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. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

The effect of mobile health educational intervention on body image and fatigue in breast cancer survivors: a randomized controlled trial. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Breast Cancer Physical Activity Mobile Intervention: Early Findings From a User Experience and Acceptability Mixed Methods Study. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Towards research-tested smartphone applications for preventing breast cancer. [2023]