RECRUITING

A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors

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 research study is evaluating the efficacy of a novel self-administered digital application for improving sexual health outcomes, quality of life, and psychological distress in hematopoietic stem cell transplant survivors.

Official Title

Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors

Quick Facts

Study Start:2025-01-27
Study Completion:2030-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06541002

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. * Adult patients (\> 18 years) who underwent autologous or allogeneic HCT \> three months prior to study enrollment
  2. * Screen positive for sexual health concerns causing distress based on the National Comprehensive Network (NCCN) survivorship guidelines screening questions
  1. * Patients who do not comprehend English or Spanish since SHIFT will only be available in these two languages for this efficacy trial.
  2. * Patients with any major uncontrolled psychiatric disorder or other comorbid cognitive conditions, which the treating HCT clinician believes would prohibit the patients' capacity to provide informed consent and participate in study procedures.

Contacts and Locations

Study Contact

Areej El-Jawahri, MD
CONTACT
617-724-4000
ael-jawahri@mgb.org
Sajeewani Samarakoon, PhD
CONTACT
ssamarakoon@mgh.harvard.edu

Study Locations (Sites)

University of Miami
Coral Gables, Florida, 33124
United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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 Date2025-01-27
Study Completion Date2030-04-30

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2030-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Sexual Dysfunction
  • Stem Cell Transplant Complications
  • Bone Marrow Transplant Complications