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

Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult Cancer Survivors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05375162

Enrollment

304

Registered

2022-05-16

Start date

2023-07-18

Completion date

2026-12-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

YACS, cancer, eHealth, physical activity, mindfulness

Brief summary

Detailed description

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. Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU) and at the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) at Wake Forest University (WFU). All YACS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures. After consent is received, all additional study procedures (i.e. assessments, orientation, intervention delivery, etc.) will be handled by the coordinating center (NU) to ensure all procedures are implemented consistently and improve efficiency. Assessments. After informed consent completion, the NU study team will send participants an email with an individual, secure link to study questionnaires and notification that an ActiGraph accelerometer packet has been mailed. Participants will be asked to complete the questionnaire within 1 week of receipt. YACS will be provided with detailed written instructions for how to wear the ActiGraph. Randomization and Study Orientation. After completing baseline assessments, YACS (n=304) will be randomized to each group using computer-generated randomly permuted blocks. After randomization, the NU study team will send the participant an intervention packet which will include the Fitbit, Fitbit instructions, instructions and a QR code to download the Opt2Move app, and instructions specific to each condition to which they are assigned. The participant will also be scheduled for an orientation phone or web call with study staff to go over the contents of the intervention packet and expectations of participation for each component in greater detail. Intervention Components Core Intervention (Fitbit + Opt2Move App). All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the Opt2Move self-monitoring app. Participants will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the 24-week study period. The core OPTIMAL AYAO app will support YACS to increase their MVPA. Participants will be provided with a weekly MVPA goal to build efficacy and ensure safe progression towards the overall goal of 150 minutes per week. Participants will be instructed to self-monitor progress towards these goals via feedback on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the Opt2Move app. 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 study team will reach out to the buddy via an email containing a description of the expectations of the buddy and a link to complete online screening. 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 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 12 week intervention. Each podcast will provide social support training and peer discussion of challenges and successes in providing YACS with MVPA support. E-coaching. 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. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours (weekends), maximum. 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. 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 recording will be accessed via the Opt2Move app. Follow-up. Participants will be instructed to maintain their MVPA during the 12-week follow-up period. They will have access to all materials to which they were assigned to less any direct contact from the study team.

Interventions

BEHAVIORALCore 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).

BEHAVIORALE-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.

BEHAVIORALGeneral 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.

BEHAVIORALMVPA-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.

BEHAVIORALBuddy

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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

The four Intervention components that are candidates for inclusion in the optimized intervention, each with 2 possible levels, will be tested in a 12-week intervention with a 12-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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

For YACS * Diagnosis of nonmetastatic cancer (except non-melanoma skin cancer) within 5 years from the time of screening / study overview session * Age Diagnosis of cancer between 18-39 years at time of diagnosis and at time of screening / study overview session * Three or more months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies * Score of 0 on two of the Exercise Preparticipation Health Screening Questionnaire items or willingness to obtain medical clearance from a primary care physician or oncologist * Self-report engagement in \<60 minutes total each week of MVPA at time of screening / study overview session * Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater) * Internet access * Fluency in spoken and written English * Willingness, at time of screening / study overview session, 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 6-month study), if assigned to that condition For "Buddies" * Friend, co-worker, caregiver or family member of a participating YACS * Age 18 years or older * Score of 0 on the Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance from a primary care physician * Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater) * Internet access * Fluency in spoken and written English * Willingness to share their Fitbit data with the study team

Exclusion criteria

* For YACS: Diagnosis of non-melanoma skin cancer * 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 in the next 12 months * Plans to move out of the United States in next 18 months * For YACS: Current enrollment in another dietary or physical activity trial * Inability to provide informed consent * Prisoners or other detained individuals

Design outcomes

Primary

Measure	Time frame	Description
Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors	24 weeks	Physical activity will be measured at baseline and at 12 and 24 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).

Secondary

Measure	Time frame	Description
Physical Function in young adult cancer survivors	24 weeks	Symptom burden on physical function will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (5=without any difficulty to 1=unable to do). The minimum value one can score is 4, and the maximum is 20. The higher scores represent better outcome.
Anxiety in young adult cancer survivors	24 weeks	Symptom burden of anxiety will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale measures uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Depression in young adult cancer survivors	24 weeks	Symptom burden of depression will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (1=never to 5=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Fatigue in young adult cancer survivors	24 weeks	Symptom burden of fatigue will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Sleep Disturbance in young adult cancer survivors	24 weeks	Symptom burden of sleep disturbance will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Sleep Impairment in young adult cancer survivors	24 weeks	Symptom burden of sleep disturbance will be measured at baseline and 12 and 24 weeks using the PROMIS Sleep-Related Impairment - Short Form 4a. This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Ability to participate in social roles and activities in young adult cancer survivors	24 weeks	Ability to participate in social roles and activities will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (5=never to 1=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome.
Applied Cognition Abilities in young adult cancer survivors	24 weeks	Symptom burden on applied cognitive abilities will be measured at baseline and 12 and 24 weeks using the PROMIS Applied Cognition-Abilities-Short Form 4a. This 4-item scale uses a 5-point Likert scale (1=not at all to 5=very much). The minimum value one can score is 4, and the maximum is 20. The higher scores represent better outcome.
Pain interference in young adult cancer survivors	24 weeks	Pain interference will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 4-item scale uses a 5-point Likert scale (5=never to 1=always). The minimum value one can score is 4, and the maximum is 20. The lower scores represent better outcome..
Pain intensity in young adult cancer survivors	24 weeks	Pain intensity will be measured at baseline and 12 and 24 weeks using the PROMIS 29 Profile v2.1. This 1-item scale uses a 11-point Likert scale (0=no pain to 10=worst pain imaginable). The minimum value one can score is 0, and the maximum is 10. The lower score represents better outcome..
Leisure Time Physical Activity in young adult cancer survivors	24 weeks	Leisure time physical activity will be measured at baseline and 12 and 24 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity. This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
Light Intensity Physical Activity	24 weeks	Light intensity physical activity will be measured at baseline and at 12 and 24 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).
Sedentary Time	24 weeks	Sedentary time will be measured at baseline and at 12 and 24 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).
Sleep Duration	24 weeks	Sleep duration will be measured at baseline and at 12 and 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days on their wrist while they sleep.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSiobhan M Phillips, PhD, MPH

Northwestern University

PRINCIPAL_INVESTIGATORDavid E Victorson, PhD