RECRUITING

IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)

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 purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood. Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not. All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today. Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.

Official Title

Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living with Likely Incurable Cancer

Quick Facts

Study Start:2024-10-28
Study Completion:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06582784

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. * Age \> 18 years
  2. * ILLIC (as determined during manual chart review)
  3. * Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9
  4. * Current owner of an iOS- or Android-compatible smartphone
  5. * Willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
  6. * Have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
  7. * English language fluency
  1. * Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9
  2. * Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:
  3. * Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or
  4. * Self-report of cognitive difficulties that impair functional independence

Contacts and Locations

Study Contact

Jennifer Dahne, Ph.D.
CONTACT
843-876-2280
dahne@musc.edu
Noelle Natale
CONTACT
843-876-9457
natalen@musc.edu

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

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 Date2024-10-28
Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-10-28
Study Completion Date2029-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Depression
  • Depressive Symptoms
  • Cancer