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

Not Applicable

Recruiting

• Conditions: Cancer; Youth Cancer; Young Adult Cancer; Distress, Psychological

• Registration Number: NCT06732375
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Study Start: 2025-06-13
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)	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 Outcome Measures

Name	Time	Method
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)	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 depression.
Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5	8 weeks	The PTSD Checklist for DSM-V (PCL-5) is a self-report measure that assesses symptoms of PTSD. The total score ranges from 0 to 80, where a higher score indicates a greater severity of PTSD symptoms
Ability to deal with stressful situations as measured by the Shift-and-Persist Scale	8 weeks	The Shift-and-Persist Scale has 14 items that measure two strategies for dealing with stressful situations: shifting, which means accepting stress and getting used to it; and persisting, which means being optimistic and finding purpose in tough times. The total score ranges from 8 to 32, where a higher score indicates a greater ability to deal with stressful situations.
Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)	8 weeks	The NCCN DT is a tool that helps identify and address distress in cancer patients. The DT is a self-reported, 11-point scale that measures distress over the past week. The scale ranges from 0 (no distress) to 10 (extreme distress).

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States