RECRUITING

Healing Track Clinical Trial

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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

This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP). The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP. This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual. The research team plans to enroll 180 participants who will be randomized into one of three groups.

Official Title

Healing Track Randomized Clinical Trial

Quick Facts

Study Start:2025-01-06

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641102

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:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 21 to 70 * Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force * Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. * Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week). * Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner. * Able to use a smartphone	* Back pain associated with compensation or litigation issues as determined by self-report within the past year * Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy * Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function * Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder * Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols

Inclusion Criteria

Exclusion Criteria

* Aged 21 to 70
* Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
* Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
* Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
* Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
* Able to use a smartphone

* Back pain associated with compensation or litigation issues as determined by self-report within the past year
* Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
* Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
* Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
* Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols

Contacts and Locations

Study Contact

Alexandra Canori, DPT, PhD

CONTACT

(212)-241-8454

alexandra.canori@mountsinai.org

Principal Investigator

Laura Tabacof, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai - Abilities Research Center

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Laura Tabacof, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2025-01-06

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2025-01-06

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Chronic Back Pain