Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-25
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Individuals without legal capacity to give consent
Individuals who are not fluent in reading, writing, and speaking English
Trial design
Design model
Single group
Treatments tested in this trial
Mindset Moments
BehavioralMM™ 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Interventional armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Time frame
8 weeksSecondary outcomes
1
Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Time frame
8 weeks2
Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the PCL-5
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
Time frame
8 weeks3
Distress as measured by the National Comprehensive Cancer Network's (NCCN) Distress Thermometer (DT)
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).
Time frame
8 weeks4
Ability to deal with stressful situations as measured by the Shift-and-Persist Scale
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.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov