RECRUITING

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a single-session mindfulness-based intervention (MBI) and an intensive 8-week MBI-Mindfulness-Oriented Recovery Enhancement (MORE) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. Aim 1: Evaluate the extent to which a brief preoperative MBI improves TKA patients' postoperative musculoskeletal health and reduces chronic opioid use. Aim 2: Evaluate the extent to which an intensive MBI (MORE) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. Aim 3: (A) Determine patient baseline characteristics that moderate MBI treatment responses. (B) Quantify the degree to which the impact of Phase 1 and 2 MBIs on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (HRV).

Official Title

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Quick Facts

Study Start:2022-05-01
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05050409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled to undergo unilateral total TKA at one of the study sites
  2. * TRICARE beneficiary
  3. * Facility with the English language that is adequate to complete study procedures.
  1. * Cognitive impairment preventing completion of study procedures,
  2. * Formal mindfulness training (e.g., MBSR, MBCT)
  3. * Severe, active suicidality
  4. * Contralateral TKA in the past 3 months or planned contralateral TKA during the study
  5. * Current cancer diagnoses.

Contacts and Locations

Study Contact

Rachel Mayhew
CONTACT
253.968.2911
rachel.j.mayhew.ctr@mail.mil
Tina Greenlee
CONTACT
tgreenlee@genevausa.org

Study Locations (Sites)

Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Knee Pain Chronic