Clinical trial NCT05375162: Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)
Official title: Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: YACS
cancer
eHealth
physical activity
mindfulness
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Wake Forest University Health Sciences
First posted: 2022-05-16
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
timeFrame: 24 weeks
Secondary outcomes:
measure: Physical Function in young adult cancer survivors
timeFrame: 24 weeks
measure: Anxiety in young adult cancer survivors
timeFrame: 24 weeks
measure: Depression in young adult cancer survivors
timeFrame: 24 weeks
measure: Fatigue in young adult cancer survivors
timeFrame: 24 weeks
measure: Sleep Disturbance in young adult cancer survivors
timeFrame: 24 weeks
measure: Sleep Impairment in young adult cancer survivors
timeFrame: 24 weeks
measure: Ability to participate in social roles and activities in young adult cancer survivors
timeFrame: 24 weeks
measure: Applied Cognition Abilities in young adult cancer survivors
timeFrame: 24 weeks
measure: Pain interference in young adult cancer survivors
timeFrame: 24 weeks
measure: Pain intensity in young adult cancer survivors
timeFrame: 24 weeks
measure: Physical self-perception in young adult cancer survivors
timeFrame: 24 weeks
measure: Confidence in ability to be regularly active in young adult cancer survivors
timeFrame: 24 weeks
measure: Confidence in ability to be regularly active despite common barriers in young adult cancer survivors
timeFrame: 24 weeks
measure: Leisure Time Physical Activity in young adult cancer survivors
timeFrame: 24 weeks
measure: Sitting time in young adult cancer survivors
timeFrame: 24 weeks
measure: Outcome expectations for exercise in young adult cancer survivors
timeFrame: 24 weeks
measure: Self-Esteem in young adult cancer survivors
timeFrame: 24 weeks
measure: Emotional Support in young adult cancer survivors
timeFrame: 24 weeks
measure: Social support for exercise in young adult cancer survivors
timeFrame: 24 weeks
measure: Mindful Awareness in young adult cancer survivors
timeFrame: 24 weeks
measure: Mindful acceptance in young adult cancer survivors
timeFrame: 24 weeks
measure: Mindful self-kindness in young adult cancer survivors
timeFrame: 24 weeks
measure: Mindful de-centering in young adult cancer survivors
timeFrame: 24 weeks
measure: Mindful presence in young adult cancer survivors
timeFrame: 24 weeks
measure: Meditation experience in young adult cancer survivors
timeFrame: baseline
measure: Meditation practice in young adult cancer survivors
timeFrame: 24 weeks
measure: Implementation feasibility measured by enrollment rate
timeFrame: 24 weeks
measure: Implementation feasibility measured by retention rate
timeFrame: 24 weeks
measure: Adherence to the OPT2MOVE app + Fitbit by young adult cancer survivors
timeFrame: 24 weeks
measure: Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey
timeFrame: 24 weeks
measure: Change in body mass index in young adult cancer survivors
timeFrame: 24 weeks
measure: Change in health behaviors in young adult cancer survivors
timeFrame: 24 weeks
measure: Change in treatment expectations in young adult cancer survivors
timeFrame: 24 weeks
measure: Change in life event related stress in young adult cancer survivors
timeFrame: 24 weeks
measure: Environmental factors in physical activity participation in young adult cancer survivors
timeFrame: 24 weeks
measure: Change in key components of multi-purpose action control framework in young adult cancer survivors
timeFrame: 24 weeks
measure: Change in executive function in young adult cancer survivors
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Northwestern University
name: Siobhan M Phillips, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
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