Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ For BCS

• Female, age 18 years or older

• Stage I-III breast cancer diagnosis within the past 5 years

• Diagnosis of cancer between 18-39 years and within the past 5 years

• ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies

• Self-report engagement in \<60 min/week of MVPA

• Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist

• Internet access and smartphone ownership

• Fluency in spoken and written English

• Willingness to find a buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 24-week study), if assigned to that condition

⁃ For Buddies

• Friend, co-worker, caregiver or family member of a participating BCS

• Age 18 years or older

• Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician

• Internet access and smartphone ownership

• Fluency in spoken and written English

• Willingness to share their Fitbit data with the study team

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Siobhan M Phillips, PhD, MPH
smphillips@northwestern.edu
312-503-4235
Backup
Hannah Freeman
hannah.freeman@northwestern.edu
312-503-2099
Time Frame
Start Date: 2024-03-24
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 304
Treatments
Experimental: Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Active_comparator: Exp Condition 2
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
Active_comparator: Exp Condition 3
Research participant receives the Core Intervention + E-Coach + Buddy
Active_comparator: Exp Condition 4
Research participant receives the Core Intervention + E-Coach
Active_comparator: Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
Active_comparator: Exp Condition 6
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
Active_comparator: Exp Condition 7
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
Active_comparator: Exp Condition 8
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
Active_comparator: Exp Condition 9
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
Active_comparator: Exp Condition 10
Research participant receives the Core Intervention + General Mindfulness Training
Active_comparator: Exp Condition 11
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
Active_comparator: Exp Condition 12
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
Active_comparator: Exp Condition 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Active_comparator: Exp Condition 14
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
Active_comparator: Exp Condition 15
Research participant receives the Core Intervention + Buddy
Active_comparator: Exp Condition 16
Research participant receives the Core Intervention
Related Therapeutic Areas
Sponsors
Leads: Northwestern University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov