CancerNCT05375162

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

A study testing Core Intervention, E-Coach and General Mindfulness Training in people with Cancer, run by Northwestern University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Cancer
What is being tested?: Core Intervention, E-Coach and General Mindfulness Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 2 sitesUnited States
Study dates: 18 Jul 2023to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Show all 18Show fewer

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Northwestern University
Chicago, Illinois, 60611
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

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

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.

Read the detailed description

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

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.

Conditions: Cancer
Being tested: Core Intervention, E-Coach, General Mindfulness Training, MVPA-Specific Mindfulness Training, Buddy
Keywords: YACS, cancer, eHealth, physical activity, mindfulness
Medical subject headings: Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core InterventionBehavioural
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).
E-CoachBehavioural
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.
General Mindfulness TrainingBehavioural
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 TrainingBehavioural
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.
BuddyBehavioural
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 groups in NCT05375162
Study group	Role	What they receive
Exp Condition 1	Experimental	Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training; Behavioral: Buddy
Exp Condition 2	Active comparator	Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training Receives: 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 Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: Buddy
Exp Condition 4	Active comparator	Research participant receives the Core Intervention + E-Coach Receives: Behavioral: Core Intervention; Behavioral: E-Coach
Exp Condition 5	Active comparator	Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: General Mindfulness Training; Behavioral: Buddy
Exp Condition 6	Active comparator	Research participant receives the Core Intervention + E-Coach + General Mindfulness Training Receives: 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 Receives: Behavioral: Core Intervention; Behavioral: E-Coach; Behavioral: MVPA-Specific Mindfulness Training; Behavioral: Buddy
Exp Condition 8	Active comparator	Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training Receives: 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 Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training; Behavioral: Buddy
Exp Condition 10	Active comparator	Research participant receives the Core Intervention + General Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training
Exp Condition 11	Active comparator	Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy Receives: Behavioral: Core Intervention; Behavioral: MVPA-Specific Mindfulness Training; Behavioral: Buddy
Exp Condition 12	Active comparator	Research participant receives the Core Intervention + MVPA Specific Mindfulness Training Receives: 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 Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training; Behavioral: Buddy
Exp Condition 14	Active comparator	Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training Receives: Behavioral: Core Intervention; Behavioral: General Mindfulness Training; Behavioral: MVPA-Specific Mindfulness Training
Exp Condition 15	Active comparator	Research participant receives the Core Intervention + Buddy Receives: Behavioral: Core Intervention; Behavioral: Buddy
Exp Condition 16	Active comparator	Research participant receives the Core Intervention Receives: Behavioral: Core Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
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).
Measured: 24 weeks

Secondary outcomes (14)

Physical Function in young adult cancer survivors
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.
Measured: 24 weeks
Anxiety in young adult cancer survivors
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.
Measured: 24 weeks
Depression in young adult cancer survivors
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.
Measured: 24 weeks
Fatigue in young adult cancer survivors
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.
Measured: 24 weeks
Sleep Disturbance in young adult cancer survivors
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.
Measured: 24 weeks
Sleep Impairment in young adult cancer survivors
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.
Measured: 24 weeks
Ability to participate in social roles and activities in young adult cancer survivors
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.
Measured: 24 weeks
Applied Cognition Abilities in young adult cancer survivors
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.
Measured: 24 weeks
Pain interference in young adult cancer survivors
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..
Measured: 24 weeks
Pain intensity in young adult cancer survivors
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..
Measured: 24 weeks
Leisure Time Physical Activity in young adult cancer survivors
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.
Measured: 24 weeks
Light Intensity Physical Activity
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).
Measured: 24 weeks
Sedentary Time
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).
Measured: 24 weeks
Sleep Duration
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.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 202331 Dec 2026

First posted16 May 2022
Study start18 Jul 2023
Primary completion6 Apr 2026
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (51)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
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.
Masking: None (open label)
Enrolment: 304 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05375162
Sponsor's protocol ID: NU 20CC10
Other IDs: 1R01CA262357-01
Status last verified: Oct 2026
First submitted: 10 Nov 2021
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Rabin C, Pinto B, Fava J. Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):41-7. doi: 10.1089/jayao.2015.0033. Epub 2015 Oct 15.
PubMed 26812450
Liu L, Moke DJ, Tsai KY, Hwang A, Freyer DR, Hamilton AS, Zhang J, Cockburn M, Deapen D. A Reappraisal of Sex-Specific Cancer Survival Trends Among Adolescents and Young Adults in the United States. J Natl Cancer Inst. 2019 May 1;111(5):509-518. doi: 10.1093/jnci/djy140.
PubMed 30321398
Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.
PubMed 27253694
Burkart M, Sanford S, Dinner S, Sharp L, Kinahan K. Future health of AYA survivors. Pediatr Blood Cancer. 2019 Feb;66(2):e27516. doi: 10.1002/pbc.27516. Epub 2018 Oct 26.
PubMed 30362237
Salsman JM, Garcia SF, Yanez B, Sanford SD, Snyder MA, Victorson D. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014 Aug 1;120(15):2247-54. doi: 10.1002/cncr.28739. Epub 2014 May 28.
PubMed 24888335
Nass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7.
PubMed 25568146
Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
PubMed 22294757
Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.
PubMed 22570317
Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.
PubMed 15850868
U.S. Department of Health and Human Services. 2018 Physical Activity Guidelines for Americans. 2018.
Brunet J, Wurz A, Shallwani SM. A scoping review of studies exploring physical activity among adolescents and young adults diagnosed with cancer. Psychooncology. 2018 Aug;27(8):1875-1888. doi: 10.1002/pon.4743. Epub 2018 Jun 5.
PubMed 29719077
Bélanger LJ, Mummery WK, Clark AM, Courneya KS. Effects of targeted print materials on physical activity and quality of life in young adult cancer survivors during and after treatment: an exploratory randomized controlled trial. Journal of Adolescent and Young Adult Oncology. 2014;3(2):83-91.
Valle CG, Tate DF, Mayer DK, Allicock M, Cai J. A randomized trial of a Facebook-based physical activity intervention for young adult cancer survivors. J Cancer Surviv. 2013 Sep;7(3):355-68. doi: 10.1007/s11764-013-0279-5. Epub 2013 Mar 27.
PubMed 23532799
Rabin C, Horowitz S, Marcus B. Recruiting young adult cancer survivors for behavioral research. J Clin Psychol Med Settings. 2013 Mar;20(1):33-6. doi: 10.1007/s10880-012-9317-0.
PubMed 22810954
Valle CG, Tate DF. Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Transl Behav Med. 2017 Dec;7(4):667-679. doi: 10.1007/s13142-017-0483-3.
PubMed 28374211

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Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

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Could I receive a placebo instead of the treatment?
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What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult Cancer Survivors
ClinicalTrials.gov ID: NCT05375162
Acronym / sponsor ID: NU 20CC10
Conditions: Cancer
Keywords: YACS, cancer, eHealth, physical activity, mindfulness
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 304 participants (estimated)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Wake Forest University Health Sciences
Study start: 18 Jul 2023 (actual)
Primary completion: 6 Apr 2026 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 16 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Intervention Components

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 16
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.

Arm	Type	Receives
Exp Condition 1	Experimental	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Exp Condition 2	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
Exp Condition 3	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: BuddyResearch participant receives the Core Intervention + E-Coach + Buddy
Exp Condition 4	Active comparator	Behavioral: Core Intervention, Behavioral: E-CoachResearch participant receives the Core Intervention + E-Coach
Exp Condition 5	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
Exp Condition 6	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + General Mindfulness Training
Exp Condition 7	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: MVPA-Specific Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
Exp Condition 8	Active comparator	Behavioral: Core Intervention, Behavioral: E-Coach, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
Exp Condition 9	Active comparator	Behavioral: Core Intervention, Behavioral: General Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + General Mindfulness Training + Buddy
Exp Condition 10	Active comparator	Behavioral: Core Intervention, Behavioral: General Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training
Exp Condition 11	Active comparator	Behavioral: Core Intervention, Behavioral: MVPA-Specific Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
Exp Condition 12	Active comparator	Behavioral: Core Intervention, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + MVPA Specific Mindfulness Training
Exp Condition 13	Active comparator	Behavioral: Core Intervention, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness Training, Behavioral: BuddyResearch participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Exp Condition 14	Active comparator	Behavioral: Core Intervention, Behavioral: General Mindfulness Training, Behavioral: MVPA-Specific Mindfulness TrainingResearch participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
Exp Condition 15	Active comparator	Behavioral: Core Intervention, Behavioral: BuddyResearch participant receives the Core Intervention + Buddy
Exp Condition 16	Active comparator	Behavioral: Core InterventionResearch participant receives the Core Intervention

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core InterventionAll 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).	Behavioural	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-CoachParticipants 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.	Behavioural	Exp Condition 1, Exp Condition 2, Exp Condition 3, Exp Condition 4, Exp Condition 5, Exp Condition 6, Exp Condition 7, Exp Condition 8
General Mindfulness TrainingParticipants 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.	Behavioural	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 TrainingParticipants 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.	Behavioural	Exp Condition 1, Exp Condition 11, Exp Condition 12, Exp Condition 13, Exp Condition 14, Exp Condition 2, Exp Condition 7, Exp Condition 8
BuddyParticipants 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.	Behavioural	Exp Condition 1, Exp Condition 11, Exp Condition 13, Exp Condition 15, Exp Condition 3, Exp Condition 5, Exp Condition 7, Exp Condition 9

Primary outcome

Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
Time frame: 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).

14 secondary outcomes

Physical Function in young adult cancer survivors
Time frame: 24 weeks
Anxiety in young adult cancer survivors
Time frame: 24 weeks
Depression in young adult cancer survivors
Time frame: 24 weeks
Fatigue in young adult cancer survivors
Time frame: 24 weeks
Sleep Disturbance in young adult cancer survivors
Time frame: 24 weeks
Sleep Impairment in young adult cancer survivors
Time frame: 24 weeks
Ability to participate in social roles and activities in young adult cancer survivors
Time frame: 24 weeks
Applied Cognition Abilities in young adult cancer survivors
Time frame: 24 weeks
Pain interference in young adult cancer survivors
Time frame: 24 weeks
Pain intensity in young adult cancer survivors
Time frame: 24 weeks
Leisure Time Physical Activity in young adult cancer survivors
Time frame: 24 weeks
Light Intensity Physical Activity
Time frame: 24 weeks
Sedentary Time
Time frame: 24 weeks
Sleep Duration
Time frame: 24 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Background: PubMed 26812450Rabin C, Pinto B, Fava J. Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):41-7. doi: 10.1089/jayao.2015.0033. Epub 2015 Oct 15.
Background: PubMed 30321398Liu L, Moke DJ, Tsai KY, Hwang A, Freyer DR, Hamilton AS, Zhang J, Cockburn M, Deapen D. A Reappraisal of Sex-Specific Cancer Survival Trends Among Adolescents and Young Adults in the United States. J Natl Cancer Inst. 2019 May 1;111(5):509-518. doi: 10.1093/jnci/djy140.
Background: PubMed 27253694Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.
Background: PubMed 30362237Burkart M, Sanford S, Dinner S, Sharp L, Kinahan K. Future health of AYA survivors. Pediatr Blood Cancer. 2019 Feb;66(2):e27516. doi: 10.1002/pbc.27516. Epub 2018 Oct 26.
Background: PubMed 24888335Salsman JM, Garcia SF, Yanez B, Sanford SD, Snyder MA, Victorson D. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014 Aug 1;120(15):2247-54. doi: 10.1002/cncr.28739. Epub 2014 May 28.
Background: PubMed 25568146Nass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7.
Background: PubMed 22294757Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
Background: PubMed 22570317Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.
Background: PubMed 15850868Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.
BackgroundU.S. Department of Health and Human Services. 2018 Physical Activity Guidelines for Americans. 2018.
Background: PubMed 29719077Brunet J, Wurz A, Shallwani SM. A scoping review of studies exploring physical activity among adolescents and young adults diagnosed with cancer. Psychooncology. 2018 Aug;27(8):1875-1888. doi: 10.1002/pon.4743. Epub 2018 Jun 5.
BackgroundBélanger LJ, Mummery WK, Clark AM, Courneya KS. Effects of targeted print materials on physical activity and quality of life in young adult cancer survivors during and after treatment: an exploratory randomized controlled trial. Journal of Adolescent and Young Adult Oncology. 2014;3(2):83-91.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Siobhan M Phillips, PhD, MPH principal investigator

Northwestern University

David E Victorson, PhD principal investigator

Northwestern University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Core Intervention, E-Coach and General Mindfulness Training in people with Cancer, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05375162, which also lists 51 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.