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NCT Number: NCT06732375

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

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.

Recruiting

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Key information

Conditions

Cancer Distress, Psychological Neoplasms Young Adult Cancer Youth Cancer

Age range

19 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Sophia K Smith, PhD, MSW

CONTACT

[email protected]

919-684-9628

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Depression 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 depression.

  2. Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5

    Time frame: 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

  3. Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)

    Time frame: 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).

  4. Ability to deal with stressful situations as measured by the Shift-and-Persist Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Pires, MS

CONTACT

[email protected]

919-660-8218

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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