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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
Must not have
Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have conditions like a recent heart attack, severe bone issues, widespread cancer, or upcoming surgery that would prevent me from exercising.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,642 Previous Clinical Trials
957,768 Total Patients Enrolled
36 Trials studying Breast Cancer
12,080 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,161 Total Patients Enrolled
941 Trials studying Breast Cancer
1,442,933 Patients Enrolled for Breast Cancer
Siobhan M Phillips, PhD, MPHPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
334 Total Patients Enrolled

Media Library

General Mindfulness Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05931874 — N/A
Breast Cancer Research Study Groups: Exp Condition 2, Exp Condition 1, Exp Condition 3, Exp Condition 4, Exp Condition 5, Exp Condition 6, Exp Condition 7, Exp Condition 8, Exp Condition 9, Exp Condition 10, Exp Condition 11, Exp Condition 12, Exp Condition 13, Exp Condition 14, Exp Condition 15, Exp Condition 16
Breast Cancer Clinical Trial 2023: General Mindfulness Training Highlights & Side Effects. Trial Name: NCT05931874 — N/A
General Mindfulness Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05931874 — N/A
~203 spots leftby Aug 2026
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