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 — BEHAVIORAL
    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 Low Touch Intervention — BEHAVIORAL
    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 Written Information — BEHAVIORAL
    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 Low Touch Intervention — BEHAVIORAL
    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 High Touch Intervention — BEHAVIORAL
    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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Ahna Pai, PhD
614-938-1601
Sarah Drake, MA
(614) 938-2252
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Lisa Schwartz, PhD
267-426-0355
Sara King-Dowling, PhD
(267) 426-5562
Penn MedicinePhiladelphiaPennsylvania19104
Chrisine Hill-Kayser, MD
215-615-6767
Kelsey Woodard, MA
9089383329

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