CancerNCT06732375
Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors
A study testing Mindset Moments in people with Cancer and Youth Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Youth Cancer, Young Adult Cancer
- What is being tested?
- Mindset Moments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals without legal capacity to give consent
- Individuals who are not fluent in reading, writing, and speaking English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Sophia K Smith, PhD, MSW, 919-684-9628, sophia.smith@duke.edu
About this study
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.
- Conditions
- Cancer, Youth Cancer, Young Adult Cancer, Distress, Psychological
- Being tested
- Mindset Moments
- Keywords
- young adult cancer survivor, distress, youth cancer survivor, resilience
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindset MomentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | 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. Receives: Behavioral: Mindset Moments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
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
Measured: 8 weeks
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).
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start13 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophia K Smith, PhD, MSW, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732375
- Sponsor's protocol ID
- Pro00116490
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT06732375
- Acronym / sponsor ID
- Pro00116490
- Conditions
- Cancer, Youth Cancer, Young Adult Cancer, Distress, Psychological
- Keywords
- young adult cancer survivor, distress, youth cancer survivor, resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Behavioral: Mindset MomentsStudy 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. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals without legal capacity to give consent
- Individuals who are not fluent in reading, writing, and speaking English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindset MomentsMM™ 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. | Behavioural | Interventional arm |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophia K Smith, PhD, MSW principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindset Moments in people with Cancer and Youth Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pires, MS (919-660-8218, andrea.pires@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.