Re-Engaging AYA Survivors in Cancer-Related Healthcare
REACH:SMART
2 other identifiers
interventional
530
1 country
3
Brief Summary
The goal of this clinical trial is to test the efficacy (how well they work) of different digital interventions that deliver information to adolescent and young adult (AYA) survivors of childhood cancer to promote re-engagement in cancer-related long-term follow-up care (LTFU). The main aims are:
- To test the efficacy of adaptive interventions (AIs) that begin with low touch intervention (LTI) as compared to written information (WI) on attending an appointment, and self-reported self-management among AYA.
- To identify the most efficacious second-stage strategy for those who initially schedule/attend an appointment (maintenance vs. step-up) and for those who do not (step-up vs. step-up maximum).
- To assess multilevel factors contributing to the effects of re-engaging AYA and how best to integrate AIs into practice. Throughout the duration of the study, participants will complete four surveys, receive a series of interventions, and may be asked to participate in an interview (post-intervention).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Aug 2025
Typical duration for not_applicable cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 15, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
February 18, 2026
February 1, 2026
2.7 years
August 15, 2025
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Re-Engagement in Care - by T4
Percentage of participants who re-engage in care (attend a LTFU appointment) by T4 as measured by electronic health record (EHR) review. If attendance is not viewable in EHR, it will be ascertained by self-report (yes/no).
36 weeks (T4)
Secondary Outcomes (7)
Re-Engagement in Care - by T3
20 weeks (T3)
AYA Self-Management (Health Knowledge Inventory)
2 times - at 20 weeks (T3) and 36 weeks (T4)
AYA Self-Management (Transition Readiness Questionnaire)
2 times - at 20 weeks (T3) and 36 weeks (T4)
AYA Self-Management (Self-Management Skills)
2 times - at 20 weeks (T3) and 36 weeks (T4)
AYA Self-Management (Health Goal Progress)
2 times - at 20 weeks (T3) and 36 weeks (T4)
- +2 more secondary outcomes
Study Arms (7)
Written Intervention + Written Intervention (Responders)
EXPERIMENTALStart with written intervention (WI) in stage 1, those who respond (schedule an appointment) in stage 1 continue receiving WI in stage 2 (maintenance).
Written Intervention + Low Touch Intervention (Responders)
EXPERIMENTALStart with written intervention (WI) in stage 1, those who respond (schedule an appointment) in stage 1, step up to receive low touch intervention (LTI) in stage 2.
Written Intervention + Low Touch Intervention (Non-Responders)
EXPERIMENTALStart with written intervention (WI) in stage 1, those who don't respond (do no schedule an appointment in stage 1), step up to receive low touch intervention (LTI) in stage 2.
Written Intervention + High Touch Intervention (Non-Responders)
EXPERIMENTALStart with written intervention (WI) in stage 1, those who don't respond (schedule and appointment) in stage 1, step up (maximum) to receive high touch intervention (HTI) in stage 2.
Low Touch Intervention + Low Touch Intervention (Responders)
EXPERIMENTALStart with low touch intervention (LTI) in stage 1, those who respond (schedule an appointment in stage 1), continue receiving LTI in stage 2 (maintenance).
Low Touch Intervention + High Touch Intervention (Responders)
EXPERIMENTALStart with low touch intervention (LTI) in stage 1, those who respond (schedule an appointment in stage 1), step up to receive high touch intervention (HTI) in stage 2.
Low Touch Intervention + High Touch Intervention (Non-Responders)
EXPERIMENTALStart with low touch intervention (LTI) in stage 1, those who don't respond (don't schedule an appointment) in stage 1, step up to receive high touch intervention (HTI) in stage 2.
Interventions
Stage 1 WI: consists of a letter from the survivorship care team with information about long-term follow-up care and relevant contacts to schedule an appointment.
Stage 1 LTI: consists of the WI stage 1 letter, a copy of their treatment summary with instructions for creating their own survivorship care plan, and one text message per week with information to schedule a follow-up care appointment.
Stage 2 WI: consists of a letter from the survivorship care team with information about what to expect at a long-term follow-up care appointment.
Stage 2 LTI: consists of the WI stage 2 letter, a copy of their treatment summary with instructions for creating their own survivorship care plan, and two to three non-tailored (generic) text messages per week related to scheduling an appointment, overcoming barriers to follow-up care, and health self-management.
Stage 2 HTI: consists of personalized mobile-friendly dashboard containing the WI letters, their treatment summary, survivorship care plan, and a growing discover section with helpful tailored resources. They will also receive four to six text messages per week with personalized messages related to their chosen health goal, personal barriers to attending cancer-related follow-up care, treatment-related risks, information about scheduling their long-term follow-up appointments, health self-management, and fun texts consisting of celebrity quotes, memes, and altruistic messages.
Eligibility Criteria
You may qualify if:
- years old
- History of a childhood cancer diagnosis, diagnosed prior to age 22
- Has not had a cancer-related follow-up visit in at least 15 months (or is 3 months past recommended follow-up)
- U.S. resident (not international patient)
- Has previously attended a cancer-related appointment at Children's Hospital of Philadelphia, or Nationwide Children's Hospital or Penn
- At least 2 years from end of treatment and 5 years from diagnosis
- English proficient
- For AYA under age 18, must have a caregiver to provide informed consent
You may not qualify if:
- Cognitive impairment limiting participation
- Received surgery only treatment
- Transferred to primary care
- Currently living with cancer diagnosis (either new, metastatic, recurrence, or relapse)
- Absence of documentation of treatment history
- Primary caregiver or other support person (e.g. partner, sibling, other caregiver)
- At least 18 years old
- U.S. resident
- English proficient
- No involvement in the AYA's healthcare
- AYA Decline support person's participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvaniacollaborator
- National Cancer Institute (NCI)collaborator
- Children's Hospital of Philadelphialead
- Nationwide Children's Hospitalcollaborator
Study Sites (3)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2025
First Posted
August 22, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02