Re-Engaging AYA Survivors in Cancer-Related Healthcare
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT07138040
- Status
- Recruiting
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 29 Years
- Healthy Volunteers
- Not accepted
Interventions
- Stage 1 Written Information — BEHAVIORALStage 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 Low Touch Intervention — BEHAVIORALStage 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 Written Information — BEHAVIORALStage 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 Low Touch Intervention — BEHAVIORALStage 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 High Touch Intervention — BEHAVIORALStage 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.
Study Details
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).
Key Dates
- Start date
- Aug 1, 2025
- Status verified
- Feb 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 530 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Written Intervention + Written Intervention (Responders)Start with written intervention (WI) in stage 1, those who respond (schedule an appointment) in stage 1 continue receiving WI in stage 2 (maintenance).
- Experimental: Written Intervention + Low Touch Intervention (Responders)Start 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.
- Experimental: Written Intervention + Low Touch Intervention (Non-Responders)Start 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.
- Experimental: Written Intervention + High Touch Intervention (Non-Responders)Start 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.
- Experimental: Low Touch Intervention + Low Touch Intervention (Responders)Start with low touch intervention (LTI) in stage 1, those who respond (schedule an appointment in stage 1), continue receiving LTI in stage 2 (maintenance).
- Experimental: Low Touch Intervention + High Touch Intervention (Responders)Start 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.
- Experimental: Low Touch Intervention + High Touch Intervention (Non-Responders)Start 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.
Primary Outcome Measure
Re-Engagement in Care - by T4 [ Time Frame: 36 weeks (T4) ]
Central Contacts
- Lisa Schwartz, PhD(267) 426-0355
- Sara King-Dowling, PhD(267) 426-5562
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | |
| Penn Medicine | Philadelphia | Pennsylvania | 19104 |
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