ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-24
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05931874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, age 18 years or older
  2. * Stage I-III breast cancer diagnosis within the past 5 years
  3. * Diagnosis of cancer between 18-39 years and within the past 5 years
  4. * ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
  5. * Self-report engagement in \<60 min/week of MVPA
  6. * 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
  7. * Internet access and smartphone ownership
  8. * Fluency in spoken and written English
  9. * 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
  10. * Friend, co-worker, caregiver or family member of a participating BCS
  11. * Age 18 years or older
  12. * 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
  13. * Internet access and smartphone ownership
  14. * Fluency in spoken and written English
  15. * Willingness to share their Fitbit data with the study team
  1. * Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
  2. * Currently pregnant or plans to become pregnant
  3. * Plans to move out of the United States in next 18 months
  4. * Current enrollment in another dietary or physical activity trial
  5. * Inability to provide informed consent
  6. * Prisoners or other detained individuals

Contacts and Locations

Principal Investigator

Siobhan M Phillips, PhD, MPH
PRINCIPAL_INVESTIGATOR
Northwestern University
David E Victorson, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Siobhan M Phillips, PhD, MPH, PRINCIPAL_INVESTIGATOR, Northwestern University
  • David E Victorson, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-24
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-03-24
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • e-health
  • physical activity
  • mindfulness

Additional Relevant MeSH Terms

  • Breast Cancer