RECRUITING

Studying Melatonin and Recovery in Teens

Quick Navigation

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 goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Official Title

SurgerySMART: Studying Melatonin and Recovery in Teens

Quick Facts

Study Start:2024-05-30

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06093477

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:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age 12-18 years * Participants undergoing elective major musculoskeletal surgery for eligible conditions * California state resident * Regular access to internet and smartphone * Can read and understand English * Biological parent or legal guardian of youth * Can read and understand English	* Prescription medication for premorbid insomnia * Cognitive impairment or developmental delay * Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication * High risk for sleep related breathing disorder * Chronic medical condition that is severe/systemic or requires regular treatment regimen * Psychiatric admission in prior 30 days * Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery * BMI ≥ 99th percentile * Enrollment in another therapeutic study * Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient\'s participation in the study

Inclusion Criteria

Exclusion Criteria

* Age 12-18 years
* Participants undergoing elective major musculoskeletal surgery for eligible conditions
* California state resident
* Regular access to internet and smartphone
* Can read and understand English
* Biological parent or legal guardian of youth
* Can read and understand English

* Prescription medication for premorbid insomnia
* Cognitive impairment or developmental delay
* Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication
* High risk for sleep related breathing disorder
* Chronic medical condition that is severe/systemic or requires regular treatment regimen
* Psychiatric admission in prior 30 days
* Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery
* BMI ≥ 99th percentile
* Enrollment in another therapeutic study
* Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient\'s participation in the study

Contacts and Locations

Study Contact

Jennifer A Rabbitts, M.B.Ch.B.

CONTACT

(650) 427-0187

surgerysmart@stanford.edu

Study Locations (Sites)

Lucile Packard Children's Hospital

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

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 Date2024-05-30

Study Completion Date2028-06

Study Record Updates