Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)

Summary

The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.

PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks

SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality

THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.

Conditions

• Cancer

Interventions

BEHAVIORAL

Core Intervention

All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit Alta HR (or similar) and the Opt2Move 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 24-week study period. 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 Opt2Move study app and provide Fitbit data to the study team in real-time. The core Opt2Move study app will support YACS 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).

BEHAVIORAL

E-Coach

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.

BEHAVIORAL

General Mindfulness Training

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 Opt2Move app.

BEHAVIORAL

MVPA-Specific Mindfulness Training

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 Opt2Move app.

BEHAVIORAL

Buddy

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 Opt2Move app modules the participant has access to for their assigned condition. The Opt2Move app will 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 podcasts (one every 3 weeks) during the first 12 weeks of the intervention. Each podcast will provide social support training and peer discussion of challenges and successes in providing YACS with MVPA support.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  collaborator OTHER

• Northwestern University

  lead OTHER

Principal Investigators

• Siobhan M Phillips, PhD, MPH · Northwestern University

• David E Victorson, PhD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-18

Primary Completion

2026-02-22

Completion

2026-02-22

Countries

• United States

Study Locations