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Pediatric Surgical ProceduresAne-RoadmapNCT06991673

Adolescent Surgery Roadmap Feasibility and Acceptability Study

A study testing Behavioral Treatment in people with Pediatric Surgical Procedures, run by University of Michigan at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. Read more about this study

Who is it for?
Ages 12 to 99 years
Conditions the study is for
Pediatric Surgical Procedures
What is being tested?
Behavioral Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesUnited States
Study dates
9 Dec 2025to Dec 2029
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 12 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient is aged 12-17 years on the date of surgery
  • Surgery is a scheduled surgery (non-emergency)
  • Surgery is occurring within the University of Michigan hospital system (University Hospital, C.S. Mott Children's Hospital, Brighton Ambulatory Surgery Center, East Ann Arbor Ambulatory Surgery Center)
  • Participants are able to enroll within 1-2 weeks of surgery
  • Patient and caregiver must be willing to participate
  • Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app
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  • Eligible patient is able to sign/assent form
  • Adolescent-caregiver dyad has at least one risk factor for adverse post-operative pain outcomes based on pre-enrollment screening (e.g., worries about managing pain, return to normal activities, limitations in doing desired activities, trouble with sleep)
  • Patient and caregiver must be willing to participate
  • Caregiver must be providing at least 50% of the patient's postsurgical caregiving
  • Caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance with institutional guidelines
  • Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app

Who cannot join

  • Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English
  • Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions
  • Foster children or wards of the state are not eligible for inclusion
  • Hardware removal or debridement surgery (not considered as painful as other orthopedic surgeries)
  • Scoliosis surgery (due to extended longitudinal relationship with surgeon)
  • Concurrent participation in another behavioral/self-management intervention trial
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  • Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate
  • Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions
  • Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English
  • Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites
  • Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center

    Ann Arbor, Michigan, 48109

  • University of Michigan affiliated hospitals

    Ann Arbor, Michigan, 48109

  • Michigan Medicine- Brighton Center for Specialty Care

    Brighton, Michigan, 48116

Other trials in United States

About this study

The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. The main questions it aims to answer are:

  • Can adolescent surgery patients and their caregivers be successfully enrolled in the study, with at least 40% of those invited choosing to participate?
  • Will participants actively use the mobile app, completing at least two activities per week for at least half of the study period, either individually and/or as a caregiver-adolescent pair?
Read more

Participants will:

  • Use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing
  • Use the app either individually or together as a caregiver-adolescent pair.
  • Complete surveys regarding risk factors for adverse postsurgical pain outcomes and physical and psychological symptoms experienced postoperatively
  • Some participants will complete a semi-structured interview in which experiences with the study and intervention activities will be elicited
Being tested
Behavioral Treatment
Keywords
positive psychology, mobile health, surgical recovery, adolescent, caregiver, pediatric surgery, mobile health intervention, positive psychology intervention

What participants receive

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

  • Behavioral TreatmentBehavioural

    Also called Positive Activity Exercises

    Positive Activity Interventions within Ane-Roadmap App

    Positive Piggy Bank - Capture happy moments by mentally savoring them, recording details, and depositing them into a "piggy bank". Open it when you need a boost.

    Gratitude Diary - Write two unique things daily for which you're grateful. Smile as you record them to enhance gratitude.

    Savoring - Each day, spend 2-3 minutes fully enjoying two positive experiences. Log them for reflection.

    Pleasant Activity Scheduling - Plan and engage in enjoyable activities at least twice weekly. Treat them as important appointments.

    Random Acts of Kindness - Perform five intentional kind acts in a day, four for others and one for yourself.

    Signature Strengths - Use a personal strength in a new way daily and reflect on its impact.

    Love Letter - Express deep appreciation to a loved one in a heartfelt letter and share it with them.

    Engaging with Beauty - Keep a log of beautiful moments in nature, art, or human kindness.

Study groups in NCT06991673
Study groupRoleWhat they receive
Positive Activity Interventions + SurveysActive comparatorIntervention arm participants will complete one of eight positive activities within the Ane-Roadmap App either as individuals or as an adolescent-caregiver team. Positive activities include gratitude journaling, planning positive experiences, savoring, identifying personal strengths, performing acts of kindness, love letters, engaging with beauty, and positive piggy bank. Participants in the intervention group will receive reminders to complete activities as an individual and as an adolescent-caregiver team. Participants will denote with a checkbox whether intervention activities were completed as an individual vs. as an adolescent-caregiver team. Participants in the control arm will have access to the Ane-Roadmap app, however all intervention activities will be turned off. Both control and intervention groups will complete daily and weekly surveys via links embedded within the Roadmap app. Reminders will be sent to participants to complete surveys each day.
Receives: Behavioral: Behavioral Treatment
Surveys OnlyNo interventionControl arm participants will not have access to the positive psychology interventions activities within the Ane-Roadmap app. They will only complete daily and weekly surveys.

What is being measured

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

  1. Recruitment Potential (Feasibility)

    The percent of eligible dyads willing to enroll (N subjects enrolled / N subjects successfully reached). This information will be derived from recruitment data. The threshold for success is that 40% of eligible dyads enroll.

    Measured: Up to 74 days (60 days post-surgery)

  2. Module Engagement (Feasibility)

    The number of days each week a Roadmap intervention module is used each week. This will be derived from app usage data. Threshold for success: Completion of any intervention module at least twice weekly for 70% of the study weeks as an individual or adolescent-caregiver team.

    Measured: Up to 74 days (60 days post-surgery)

  3. Module Engagement (Feasibility)

    The number of days each week a Roadmap intervention module is used as an adolescent-caregiver team each week. This will be derived from app usage data. Threshold for success: 2) 50% of participants will complete Roadmap intervention activities as a team at least one time for 50% of the study weeks.

    Measured: Up to 74 days (60 days post-surgery)

Secondary outcomes (8)
  1. Adolescent Global Health

    Adolescent Global Health, assessed by Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 (Minimum value: 12, Maximum value: 120). Higher scores on positive domains (Physical Function and Peer Relationships) = Better outcome. Higher scores on negative domains (Anxiety, Depressive Symptoms, Fatigue, Pain Interference, Pain Intensity) = Worse outcome.

    Measured: Up to 74 days (60 days post-surgery)

  2. Caregiver Global Health

    Caregiver Global Health assessed using Patient-Reported Outcomes Measurement Information System 29+2 Profile Version 2.1 (Minimum score: 16, Maximum score 160). Higher scores on positive domains (Physical Function, Ability to Participate in Social Roles and Activities) = Better outcome. Higher scores on negative domains (Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, Pain Intensity) = Worse outcome.

    Measured: Up to 74 days (60 days post-surgery)

  3. Adolescent pain intensity

    Adolescent pain intensity, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Pain Intensity (Minimum value: 0, Maximum value: 10). Higher scores indicate a worse outcome, representing greater pain intensity.

    Measured: Up to 74 days (60 days post-surgery)

  4. Adolescent Pain Interference

    Adolescent pain interference, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Pain Interference Short Form 8a (Minimum value: 0, Maximum value: 10). Higher scores indicate a worse outcome, representing greater interference of pain with daily activities and functioning.

    Measured: Up to 74 days (60 days post-surgery)

  5. Adolescent Mood

    Adolescent mood, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Depressive Symptoms - Mood Subscale (minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, representing greater depressive symptoms.

    Measured: Up to 74 days (60 days post-surgery)

  6. Adolescent anxiety

    Adolescent anxiety, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Anxiety - Anxiety Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater anxiety symptoms.

    Measured: Up to 74 days (60 days post-surgery)

  7. Caregiver anxiety

    Caregiver anxiety, assessed using Patient-Reported Outcomes Measurement Information System Anxiety Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater anxiety symptoms.

    Measured: Up to 74 days (60 days post-surgery)

  8. Caregiver mood

    Caregiver mood, assessed using Patient-Reported Outcomes Measurement Information System Mood Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater negative mood symptoms.

    Measured: Up to 74 days (60 days post-surgery)

Timeline

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

  1. First posted28 May 2025
  2. Study start9 Dec 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06991673
Sponsor's protocol ID
HUM00265431
Acronym
Ane-Roadmap
Status last verified
Jul 2026
First submitted
16 May 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Whittle R, Mansell G, Jellema P, van der Windt D. Applying causal mediation methods to clinical trial data: What can we learn about why our interventions (don't) work? Eur J Pain. 2017 Apr;21(4):614-622. doi: 10.1002/ejp.964. Epub 2016 Oct 14.

    PubMed 27739626
  • Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013 Jun;18(2):137-50. doi: 10.1037/a0031034. Epub 2013 Feb 4.

    PubMed 23379553
  • Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.

    PubMed 3806354
  • Bryant FB. A four-factor model of perceived control: Avoiding, coping, obtaining, and savoring. J Pers. 1989;57(4):773-797.

  • Kashdan TB, Uswatte G, Julian T. Gratitude and hedonic and eudaimonic well-being in Vietnam war veterans. Behav Res Ther. 2006 Feb;44(2):177-99. doi: 10.1016/j.brat.2005.01.005.

    PubMed 16389060
  • Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. doi: 10.1037//0022-3514.84.2.377.

    PubMed 12585811
  • Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.

    PubMed 16045394
  • Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26.

    PubMed 22203645
  • Fauer A, Hoodin F, Byrd M, et al. The role of family caregiving in adult and pediatric allogeneic hematopoietic cell transplantation: Using health information technology to advance patient-centered care. Biol Blood Marrow Transplant. 2018;24(3):S484-S485.

  • Runaas L, Hoodin F, Kentor R, et al. User-centered design and development of a personalized mobile health application for adult HCT patients in the inpatient setting. Biol Blood Marrow Transplant. 2017;23(3):S419-S420.

  • Runaas L, Hoodin F, Munaco A, Fauer A, Sankaran R, Churay T, Mohammed S, Seyedsalehi S, Chappell G, Carlozzi N, Fetters MD, Kentor R, McDiarmid L, Brookshire K, Warfield C, Byrd M, Kaziunas S, Maher M, Magenau J, An L, Cohn A, Hanauer DA, Choi SW. Novel Health Information Technology Tool Use by Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation: Longitudinal Quantitative and Qualitative Patient-Reported Outcomes. JCO Clin Cancer Inform. 2018 Dec;2:1-12. doi: 10.1200/CCI.17.00110.

    PubMed 30652535
  • Runaas L, Hanauer D, Maher M, Bischoff E, Fauer A, Hoang T, Munaco A, Sankaran R, Gupta R, Seyedsalehi S, Cohn A, An L, Tewari M, Choi SW. BMT Roadmap: A User-Centered Design Health Information Technology Tool to Promote Patient-Centered Care in Pediatric Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2017 May;23(5):813-819. doi: 10.1016/j.bbmt.2017.01.080. Epub 2017 Jan 27.

    PubMed 28132870
  • Runaas L, Bischoff E, Hoodin F, et al. A novel health informatics tool to improve caregiver activation: Findings from pediatric BMT in a hospital-based setting. Blood. 2016;128(22):2382-2382.

  • Grossman LV, Choi SW, Collins S, Dykes PC, O'Leary KJ, Rizer M, Strong P, Yen PY, Vawdrey DK. Implementation of acute care patient portals: recommendations on utility and use from six early adopters. J Am Med Inform Assoc. 2018 Apr 1;25(4):370-379. doi: 10.1093/jamia/ocx074.

    PubMed 29040634
  • Kaziunas E, Hanauer DA, Ackerman MS, Choi SW. Identifying unmet informational needs in the inpatient setting to increase patient and caregiver engagement in the context of pediatric hematopoietic stem cell transplantation. J Am Med Inform Assoc. 2016 Jan;23(1):94-104. doi: 10.1093/jamia/ocv116. Epub 2015 Oct 28.

    PubMed 26510878

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Treatment in people with Pediatric Surgical Procedures, run by University of Michigan at 3 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 12 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Recruitment Potential (Feasibility) (time frame: Up to 74 days (60 days post-surgery)). The study lists 3 primary outcomes in all. 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 NCT06991673, which also lists 154 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 29 Jul 2026.

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