Adolescent Surgery Roadmap Feasibility and Acceptability Study

Overview

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? 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

Interventions

• Behavioral Behavioral Treatment
  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 en

Primary outcome measures

• Recruitment Potential (Feasibility) [Time frame: Up to 74 days (60 days post-surgery)]
• Module Engagement (Feasibility) [Time frame: Up to 74 days (60 days post-surgery)]
• Module Engagement (Feasibility) [Time frame: Up to 74 days (60 days post-surgery)]

Secondary outcome measures (8)

• Adolescent Global Health [Time frame: Up to 74 days (60 days post-surgery)]
• Caregiver Global Health [Time frame: Up to 74 days (60 days post-surgery)]
• Adolescent pain intensity [Time frame: Up to 74 days (60 days post-surgery)]
• Adolescent Pain Interference [Time frame: Up to 74 days (60 days post-surgery)]
• Adolescent Mood [Time frame: Up to 74 days (60 days post-surgery)]
• Adolescent anxiety [Time frame: Up to 74 days (60 days post-surgery)]
• Caregiver anxiety [Time frame: Up to 74 days (60 days post-surgery)]
• Caregiver mood [Time frame: Up to 74 days (60 days post-surgery)]

Eligibility criteria

Inclusion Criteria (Adolescent Patient):

• 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
• 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)

Inclusion Criteria (Caregiver):

• 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

Exclusion Criteria (Adolescent Patient):

• 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
• Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate

Exclusion Criteria (Caregiver):

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center — Ann Arbor
• University of Michigan affiliated hospitals — Ann Arbor
• Michigan Medicine- Brighton Center for Specialty Care — Brighton

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 22203645

Identifiers

NCT: NCT06991673 · HUM00265431

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗