304 Participants Needed

Mobile Health + Mindfulness for Breast Cancer Survivors

(F2TMind Trial)

SM
BE
HF
Overseen ByHannah Freeman
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.26789

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.12101112

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

SM

Siobhan M Phillips, PhD, MPH

Principal Investigator

Northwestern University

DE

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.
See 10 more

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
See 3 more

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
16Treatment groups
Experimental Treatment
Active Control
Group I: Exp Condition 1Experimental Treatment5 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Group II: Exp Condition 2Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
Group III: Exp Condition 3Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + Buddy
Group IV: Exp Condition 4Active Control2 Interventions
Research participant receives the Core Intervention + E-Coach
Group V: Exp Condition 5Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
Group VI: Exp Condition 6Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
Group VII: Exp Condition 7Active Control4 Interventions
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
Group VIII: Exp Condition 8Active Control3 Interventions
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
Group IX: Exp Condition 9Active Control3 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
Group X: Exp Condition 10Active Control2 Interventions
Research participant receives the Core Intervention + General Mindfulness Training
Group XI: Exp Condition 11Active Control3 Interventions
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
Group XII: Exp Condition 12Active Control2 Interventions
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
Group XIII: Exp Condition 13Active Control4 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Group XIV: Exp Condition 14Active Control3 Interventions
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
Group XV: Exp Condition 15Active Control2 Interventions
Research participant receives the Core Intervention + Buddy
Group XVI: Exp Condition 16Active Control1 Intervention
Research participant receives the Core Intervention

Find a Clinic Near You

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

References

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. [2022]
Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]
[Effects of Mindfulness Meditation program on perceived stress, ways of coping, and stress response in breast cancer patients]. [2015]
Randomized Controlled Trial of a 4-Week Mindfulness Intervention among Cancer Survivors Compared to a Breathing Control. [2019]
The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. [2020]
Mindful exercise, quality of life, and survival: a mindfulness-based exercise program for women with breast cancer. [2015]
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]
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]
The wearable activity technology and action-planning trial in cancer survivors: Physical activity maintenance post-intervention. [2021]
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 Statespubmed.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]
Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors. [2022]
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