RECRUITING

A Preliminary Evaluation of Digital Behavioral Interventions

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

Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.

Official Title

A Preliminary Evaluation of Digital Behavioral Interventions

Quick Facts

Study Start:2025-08-12
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07160439

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * (1) age = 18 years;(2) 0-5 years post-diagnosis of Stage I, II, or III female breast cancer; (3) elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score \> 9) or GAD-7 (score \> 7)
  1. * (1) receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks); (2) active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources (3) do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later); and (4) cannot read and speak English (interventions only available in English)

Contacts and Locations

Study Contact

Philip Chow, PhD
CONTACT
9146453458
pic2u@virginia.edu

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22904
United States

Collaborators and Investigators

Sponsor: University of Virginia

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 Date2025-08-12
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Anxiety
  • Well-Being

Additional Relevant MeSH Terms

  • Mental Health Issue
  • Breast Cancer