Recruiting

Mindset Moments™

Sponsor:

Duke University

Code:

NCT06732375

Conditions

Cancer

Youth Cancer

Young Adult Cancer

Distress, Psychological

Eligibility Criteria

Sex: All

Age: 19 - 25

Healthy Volunteers: Accepted

Interventions

Mindset Moments

Study Details

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

Study ID

NCT06732375

Start date

Jun 13, 2025

Status verified date

Dec, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 25

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Interventional arm

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.

Interventions

Mindset Moments

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.

Primary outcome measure

  • Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Andrea Pires, MS

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

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Sophia K Smith, PhD, MSW

919-684-9628sophia.smith@duke.edu

More Information

Sponsor

Duke University

Last update posted

May 6, 2026

Last verified

Dec, 2025

Keywords

  • young adult cancer survivor
  • distress
  • youth cancer survivor
  • resilience

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-06.