Mobile Health + Mindfulness for Breast Cancer Survivors

(F2TMind Trial)

Overseen By Hannah Freeman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Metastatic disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

304 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants may still be undergoing endocrine or hormone therapies, suggesting that some medications might be allowed.

What data supports the effectiveness of the treatment Mobile Health + Mindfulness for Breast Cancer Survivors?

Research shows that mindfulness training can improve quality of life and reduce stress in breast cancer patients. Studies have found that mindfulness programs can help with psychological distress, attention, and symptom management, suggesting potential benefits for breast cancer survivors. ^{1 2 3 4 5}

Is mindfulness-based therapy safe for breast cancer survivors?

Research suggests that mindfulness-based therapy is generally safe for breast cancer survivors, as it has been used to improve psychological well-being without reported safety concerns. ^{2 6 7 8 9}

How is the Mobile Health + Mindfulness treatment for breast cancer survivors different from other treatments?

This treatment is unique because it combines mindfulness training with mobile health technology to improve quality of life and physical activity in breast cancer survivors, offering a convenient and accessible way to support mental and physical health. ^{1 2 10 11 12}

What is the purpose of this trial?

The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration. Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks. Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality. Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.

Research Team

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

David E Victorson, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for female breast cancer survivors, aged 18 or older, with a Stage I-III diagnosis in the past 5 years and less than 60 minutes of moderate to vigorous physical activity per week. They must have internet access, a smartphone, speak English fluently, and be post-primary treatment. Buddies supporting them should also meet similar criteria.

Inclusion Criteria

I am physically ready for breast cancer surgery, or willing to get a doctor's approval.

For BCS: Internet access and smartphone ownership

I am willing to share my Fitbit data with the research team.

Exclusion Criteria

Inability to provide informed consent

You are planning to leave the United States within the next 18 months.

Current enrollment in another dietary or physical activity trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (online, phone, or in-person)

Baseline Assessment

Participants complete baseline assessments and are randomized into intervention groups

1 week

1 visit (online)

Intervention

Participants engage in a 24-week intervention involving mHealth components to increase MVPA

24 weeks

Weekly self-monitoring and virtual check-ins

Follow-up

Participants maintain MVPA and are monitored for outcomes without direct contact from the study team

24 weeks

Treatment Details

Interventions

• General Mindfulness Training
• MVPA-Specific Mindfulness Training

Trial Overview The study tests how different mHealth components like social support (E-Coach or Buddy) and mindfulness training (general or MVPA-specific) affect physical activity levels over a period of up to one year in breast cancer survivors.

Participant Groups

Group I: Exp Condition 1 Experimental Treatment 5 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group II: Exp Condition 2 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training

Group III: Exp Condition 3 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + Buddy

Group IV: Exp Condition 4 Active Control 2 Interventions

Research participant receives the Core Intervention + E-Coach

Group V: Exp Condition 5 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy

Group VI: Exp Condition 6 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training

Group VII: Exp Condition 7 Active Control 4 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy

Group VIII: Exp Condition 8 Active Control 3 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training

Group IX: Exp Condition 9 Active Control 3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + Buddy

Group X: Exp Condition 10 Active Control 2 Interventions

Research participant receives the Core Intervention + General Mindfulness Training

Group XI: Exp Condition 11 Active Control 3 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy

Group XII: Exp Condition 12 Active Control 2 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training

Group XIII: Exp Condition 13 Active Control 4 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group XIV: Exp Condition 14 Active Control 3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training

Group XV: Exp Condition 15 Active Control 2 Interventions

Research participant receives the Core Intervention + Buddy

Group XVI: Exp Condition 16 Active Control 1 Intervention

Research participant receives the Core Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Women with breast cancer who used a mobile app for mindfulness training reported significantly higher quality of life compared to those in the waitlist control group over an 8-week period.

The mindfulness training also led to increased dispositional mindfulness in participants, indicating that the app may help improve mental well-being alongside physical health after a breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. Rosen, KD., Paniagua, SM., Kazanis, W., et al.[2022]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., et al.[2022]

The Mindfulness Meditation program significantly reduced perceived stress, emotional coping, salivary cortisol levels, and psychological stress responses in 50 breast cancer patients over 8 weeks, compared to a control group.

This program is an effective nursing intervention for managing stress in breast cancer patients, although it did not show significant differences in problem-focused coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of Mindfulness Meditation program on perceived stress, ways of coping, and stress response in breast cancer patients]. Kang, G., Oh, S.[2015]

A 4-week mindfulness program for 36 cancer survivors led to significant reductions in perceived stress and sedentary time, along with improvements in sleep quality and daily physical activity after the intervention.

The study suggests that abbreviated mindfulness interventions are feasible and effective for cancer survivors, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. Wirth, MD., Franco, R., Wagner Robb, S., et al.[2019]

Mindfulness-based music therapy (MBMT) has shown significant benefits in improving attention and reducing negative mood and fatigue in women undergoing adjuvant chemotherapy for breast cancer, as indicated by a pilot study.

The study highlights the potential of integrating music therapy with mindfulness practices to enhance the overall well-being of breast cancer patients, suggesting further exploration of music's role in mindfulness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Lesiuk, T.[2020]

This pilot study will involve 30 women with breast cancer, focusing on the integration of mindfulness and exercise over 8 weeks to assess its impact on anxiety, depression, quality of life, and PTSD symptoms.

If the initial results show significant benefits, the program may be refined and potentially lead to the creation of a Mindfulness-based Exercise Program Manual for broader use in supporting cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful exercise, quality of life, and survival: a mindfulness-based exercise program for women with breast cancer. Tacón, AM., McComb, J.[2015]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

In a pilot study of 23 breast cancer survivors with high depressive symptoms, an 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved mental well-being, increasing resilience and quality of life while reducing depression, anxiety, and insomnia symptoms.

Despite these psychological improvements, there were no changes in stress biomarkers or a correlation between the amount of mindfulness practice and the outcomes, suggesting that the benefits of MBSR may stem from factors beyond just practice time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness is associated with improved psychological well-being but no change in stress biomarkers in breast cancer survivors with depression: a single group clinical pilot study. Sakki, SE., Penttinen, HM., Hilgert, OM., et al.[2022]

The study involving 68 cancer survivors showed that a distance-based intervention using wearable technology significantly increased moderate-to-vigorous physical activity (MVPA) levels, which were maintained 12 weeks after the intervention ended.

At 24 weeks, the intervention group continued to engage in higher levels of MVPA compared to the control group, indicating that such interventions can have lasting effects on physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. Hardcastle, SJ., Maxwell-Smith, C., Hince, D., 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]

The ACTIVATE Trial demonstrated that using a Garmin Vivofit 2 activity monitor, along with behavioral coaching, significantly increased moderate to vigorous physical activity (MVPA) by an average of 69 minutes per week in breast cancer survivors over a 12-week period.

Participants in the intervention group also experienced a significant reduction in sedentary behavior, with decreases of 37 minutes per day in total sitting time and 42 minutes per day in prolonged sitting bouts, highlighting the effectiveness of wearable technology in promoting a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

The mobile mindfulness-based stress reduction program (mMBSR(BC)) was found to be feasible and acceptable for breast cancer survivors, with significant improvements in psychological and physical symptoms after 6 weeks of use.

Participants showed medium to large effect size improvements in symptoms such as depression, anxiety, stress, and quality of life, indicating that this mobile intervention can effectively reduce symptom burden during the survivorship phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. Lengacher, CA., Reich, RR., Ramesar, S., et al.[2022]

References

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

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

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

[Effects of Mindfulness Meditation program on perceived stress, ways of coping, and stress response in breast cancer patients]. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]

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

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. [2020]

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

Mindful exercise, quality of life, and survival: a mindfulness-based exercise program for women with breast cancer. [2015]

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

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness is associated with improved psychological well-being but no change in stress biomarkers in breast cancer survivors with depression: a single group clinical pilot study. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. [2021]

10. 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]

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

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. [2022]