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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06732375
Enrollment
40
Registered
2024-12-13
Start date
2025-06-13
Completion date
2027-03-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

young adult cancer survivor, distress, youth cancer survivor, resilience

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.

Interventions

BEHAVIORALMindset 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)8 weeks8-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

MeasureTime frameDescription
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)8 weeks8-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-58 weeksThe 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
Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)8 weeksThe 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).
Ability to deal with stressful situations as measured by the Shift-and-Persist Scale8 weeksThe 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.

Countries

United States

Contacts

CONTACTAndrea Pires, MS
andrea.pires@duke.edu919-660-8218
PRINCIPAL_INVESTIGATORSophia K Smith, PhD, MSW

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026