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Clinical Trials/NCT06732375
NCT06732375
Recruiting
Not Applicable

Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors

Duke University1 site in 1 country40 target enrollmentJune 13, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Duke University
Enrollment
40
Locations
1
Primary Endpoint
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

The purpose of this study is to evaluate the feasibility and acceptability of the Mindset Moments™ (MM™) program in managing psychological distress and resiliency in adolescent and young adult cancer survivors.

Study participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT check in within the app. Participants will also be asked to complete an online survey at the time of enrollment and at 4 and 8 weeks.

Registry
clinicaltrials.gov
Start Date
June 13, 2025
End Date
September 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 19-25 years of age
  • Prior AYA cancer diagnosis
  • Completed primary treatment for their cancer
  • Score of 3 or above on the Distress Thermometer at the time of recruitment

Exclusion Criteria

  • Individuals without legal capacity to give consent
  • Individuals who are not fluent in reading, writing, and speaking English

Outcomes

Primary Outcomes

Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

Time Frame: 8 weeks

8-measure short form to assess the severity of anxiety symptoms within the Patient-Reported Outcomes Measurement Information System (PROMIS) framework. The total score ranges from 8 to 40, where a higher score indicates greater anxiety.

Secondary Outcomes

  • Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)(8 weeks)
  • Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5(8 weeks)
  • Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)(8 weeks)
  • Ability to deal with stressful situations as measured by the Shift-and-Persist Scale(8 weeks)

Study Sites (1)

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