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

NCT05931874 | Active Not Recruiting DMC

• 2 other identifiers: NU 22CC05R01CA266178
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; e-health; physical activity; mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors

  Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.

  48 weeks

Secondary Outcomes (27)

• Anxiety in breast cancer survivors

  48 weeks

• Depression in breast cancer survivors

  48 weeks

• Fatigue in breast cancer survivors

  48 weeks

• Physical Function in breast cancer survivors

  48 weeks

• Sleep Disturbance in breast cancer survivors

  48 weeks

Study Arms (16)

Exp Condition 1

EXPERIMENTAL

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 2

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 3

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + Buddy

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy

Exp Condition 4

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach

Behavioral: Core Intervention; Behavioral: E-Coach

Exp Condition 5

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: General Mindfulness Training

Exp Condition 6

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training

Exp Condition 7

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 8

ACTIVE COMPARATOR

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training

Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 9

ACTIVE COMPARATOR

Research participant receives the Core Intervention + General Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: General Mindfulness Training

Exp Condition 10

ACTIVE COMPARATOR

Research participant receives the Core Intervention + General Mindfulness Training

Behavioral: Core Intervention; Behavioral: General Mindfulness Training

Exp Condition 11

ACTIVE COMPARATOR

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 12

ACTIVE COMPARATOR

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training

Behavioral: Core Intervention; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 13

ACTIVE COMPARATOR

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Behavioral: Core Intervention; Behavioral: Buddy; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 14

ACTIVE COMPARATOR

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training

Behavioral: Core Intervention; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training

Exp Condition 15

ACTIVE COMPARATOR

Research participant receives the Core Intervention + Buddy

Behavioral: Core Intervention; Behavioral: Buddy

Exp Condition 16

ACTIVE COMPARATOR

Research participant receives the Core Intervention

Behavioral: Core Intervention

Interventions

Core Intervention BEHAVIORAL

All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit Alta HR (or similar) and the study self-monitoring app. Participants will be provided with the Fitbit Alta HR. They will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the study. The Fitbit measures PA intensity, steps, and heart rate, and it syncs directly with the Ftibit app on the smartphone which will ill automatically sync with the study app and provide Fitbit data to the study team in real-time. The core study app will support BCS to increase their MVPA. The app will also contain educational information on MVPA and effective behavior change strategies for building self-efficacy, overcoming barriers, enhancing facilitators, setting realistic outcome expectations, and self-regulatory skill-building (i.e., reviewing progress, goal setting, action-planning and coping with disruptions).

Exp Condition 1; Exp Condition 10; Exp Condition 11; Exp Condition 12; Exp Condition 13; Exp Condition 14; Exp Condition 15; Exp Condition 16; Exp Condition 2; Exp Condition 3; Exp Condition 4; Exp Condition 5; Exp Condition 6; Exp Condition 7; Exp Condition 8; Exp Condition 9

E-Coach BEHAVIORAL

Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. Text message protocols will be informed by the investigators' previous experience using telephone coaching to promote MVPA in cancer survivors. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance.

Exp Condition 1; Exp Condition 2; Exp Condition 3; Exp Condition 4; Exp Condition 5; Exp Condition 6; Exp Condition 7; Exp Condition 8

Buddy BEHAVIORAL

Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The study app include a buddy module where the buddy and participant can view each other's progress. The buddy will be expected to attend a 15-30 minute group orientation call and listen to four 10-15 minute podcast (one every 3 weeks) during the first 24 weeks of the intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support.

Exp Condition 1; Exp Condition 11; Exp Condition 13; Exp Condition 15; Exp Condition 3; Exp Condition 5; Exp Condition 7; Exp Condition 9

General Mindfulness Training BEHAVIORAL

Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app.

Exp Condition 1; Exp Condition 10; Exp Condition 13; Exp Condition 14; Exp Condition 2; Exp Condition 5; Exp Condition 6; Exp Condition 9

MVPA-Specific Mindfulness Training BEHAVIORAL

Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recordings will be accessed via the study app.

Exp Condition 1; Exp Condition 11; Exp Condition 12; Exp Condition 13; Exp Condition 14; Exp Condition 2; Exp Condition 7; Exp Condition 8

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
• Currently pregnant or plans to become pregnant
• Plans to move out of the United States in next 18 months
• Current enrollment in another dietary or physical activity trial
• Inability to provide informed consent
• Prisoners or other detained individuals

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Siobhan M Phillips, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The four Intervention components that are candidates for inclusion in the optimized intervention, each with 2 possible levels, will be tested in a 24-week intervention with a 24-week follow-up using a MOST approach. The effects of the four individual intervention components and their combinations will be examined via a full factorial experiment. The investigators chose a factorial experimental design because these designs have two characteristics essential to the success of MOST. They: a) separate component effects enabling the estimation of the main effect of each candidate component and interactions between components and b) are more economical compared to alternative designs because they often require substantially fewer subjects to achieve the same power and use less resources. The investigators are using a full factorial experiment with 2\^4=16 experimental conditions.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 5, 2023
• Study Start: March 24, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)