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Behavioural Intervention
Mobile Health + Mindfulness for Breast Cancer Survivors (F2TMind Trial)
N/A
Recruiting
Led By Siobhan M Phillips, PhD, MPH
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For BCS: Female, age 18 years or older
For 'Buddies': Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
F2TMind Trial Summary
This trial will examine how 4 mHealth interventions can help breast cancer survivors increase their physical activity and improve symptom burden, activity intensity and sleep quality.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focusing on exercise and mindfulness training, traditional side effects associated with medications are not expected. Participants may experience fatigue or stress related to new activities.
F2TMind Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
Select...
I am 18 years old or older.
F2TMind Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Secondary outcome measures
Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey
Adherence to the study app + Fitbit by breast cancer survivors
Anxiety in breast cancer survivors
+24 moreF2TMind Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buddy
2017
N/A
~3290
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,783 Total Patients Enrolled
38 Trials studying Breast Cancer
12,171 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,137 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,056 Patients Enrolled for Breast Cancer
Siobhan M Phillips, PhD, MPHPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
334 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am physically ready for breast cancer surgery, or willing to get a doctor's approval.I am willing to share my Fitbit data with the research team.I am a woman aged 18 or older.I am 18 years old or older.You are planning to leave the United States within the next 18 months.I finished my main cancer treatment over 3 months ago but may still be on hormone therapy.You report being not active enough, doing less than an hour of moderate to vigorous physical activity each week.I don't have conditions like a recent heart attack, severe bone issues, widespread cancer, or upcoming surgery that would prevent me from exercising.I was diagnosed with Stage I-III breast cancer in the last 5 years.I was diagnosed with cancer between the ages of 18-39 and within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Exp Condition 2
- Group 2: Exp Condition 1
- Group 3: Exp Condition 3
- Group 4: Exp Condition 4
- Group 5: Exp Condition 5
- Group 6: Exp Condition 6
- Group 7: Exp Condition 7
- Group 8: Exp Condition 8
- Group 9: Exp Condition 9
- Group 10: Exp Condition 10
- Group 11: Exp Condition 11
- Group 12: Exp Condition 12
- Group 13: Exp Condition 13
- Group 14: Exp Condition 14
- Group 15: Exp Condition 15
- Group 16: Exp Condition 16
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still open?
"According to the information on clinicaltrials.gov, this trial is not currently recruiting patients. It was first posted on September 5th 2023 and last updated June 16th 2023; however, there are presently 2657 other trials that are actively enrolling participants as of now."
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