Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindset Moments.
- Who it may be relevant to
- Registry conditions: Cancer, Youth Cancer, Young Adult Cancer, Distress, Psychological. Basic parameters: 19 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral 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 measures
- Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: 8 weeks]
Secondary outcome measures (4)
- Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: 8 weeks]
- Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5 [Time frame: 8 weeks]
- Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT) [Time frame: 8 weeks]
- Ability to deal with stressful situations as measured by the Shift-and-Persist Scale [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke Cancer Institute — Durham
Identifiers
NCT: NCT06732375 · Pro00116490