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

NCT06732375 | Recruiting

• 1 other identifier: Pro00116490
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Youth Cancer; Young Adult Cancer; Distress, Psychological

Keywords

young adult cancer survivor; distress; youth cancer survivor; resilience

Outcome Measures

Primary Outcomes (1)

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

  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.

  8 weeks

Secondary Outcomes (4)

• 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 Arms (1)

Interventional arm

EXPERIMENTAL

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 (cognitive behavioral therapy) check-in within the app.

Behavioral: Mindset Moments

Interventions

Mindset Moments BEHAVIORAL

MM™ includes: 1) CBT; 2) resilience training; 3) mindfulness-based stress reduction; 4) peer support; and 5) family conversations delivered in small virtual groups, with a "mentor" who facilitates resilience-building conversations prompted from "Skill of the Week" lessons.

Interventional arm

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sophia K Smith, PhD, MSW

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Pires, MS

CONTACT

919-660-8218; andrea.pires@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: June 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)