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

NCT ID: NCT06732375

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Cancer Youth Cancer Young Adult Cancer Distress, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindset Moments

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophia K Smith, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Cancer Institute

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Pires, MS

Role: CONTACT

919-660-8218

Facility Contacts

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Sophia K Smith, PhD, MSW

Role: primary

919-684-9628

Other Identifiers

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Pro00116490

Identifier Type: -

Identifier Source: org_study_id

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