Recruiting

Adaptive Interventions

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07138040

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 15 - 29

Healthy Volunteers: Not accepted

Interventions

Stage 1 Written Information

Stage 1 Low Touch Intervention

Stage 2 Written Information

Stage 2 Low Touch Intervention

Stage 2 High Touch Intervention

Study Details

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).

Conditions

Cancer

Study ID

NCT07138040

Start date

Aug 1, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria for AYA

1. 15-29 years old
2. History of a childhood cancer diagnosis, diagnosed prior to age 22
3. Has not had a cancer-related follow-up visit in at least 15 months (or is 3 months past recommended follow-up)
4. U.S. resident (not international patient)
5. Has previously attended a cancer-related appointment at Children's Hospital of Philadelphia, or Nationwide Children's Hospital or Penn
6. At least 2 years from end of treatment and 5 years from diagnosis
7. English proficient
8. For AYA under age 18, must have a caregiver to provide informed consent

Exclusion Criteria for AYA

1. Cognitive impairment limiting participation
2. Received surgery only treatment
3. Transferred to primary care
4. Currently living with cancer diagnosis (either new, metastatic, recurrence, or relapse)
5. Absence of documentation of treatment history
6. Absence of inclusion criteria above

Inclusion Criteria for Support Person of AYA

1. Primary caregiver or other support person (e.g. partner, sibling, other caregiver)
2. At least 18 years old
3. U.S. resident
4. English proficient

Exclusion Criteria for Support Person of AYA

1. No involvement in the AYA's healthcare
2. AYA Decline support person's participation
3. Absence of inclusion criteria above

Study Design

Enrollment

530 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Stage 1 Written Information

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

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

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

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

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.

Primary outcome measure

  • Re-Engagement in Care - by T4 [ Time Frame: 36 weeks (T4) ]

Central Contacts and Locations

Central contacts

Lisa Schwartz, PhD

(267) 426-0355SCHWARTZL@chop.edu

Sara King-Dowling, PhD

(267) 426-5562kingdowlis@chop.edu

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Ahna Pai, PhD

614-938-1601ahna.pai@nationwidechildrens.org

Sarah Drake, MA

(614) 938-2252Sarah.Drake2@nationwidechildrens.org

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lisa Schwartz, PhD

267-426-0355SCHWARTZL@chop.edu

Sara King-Dowling, PhD

(267) 426-5562kingdowlis@chop.edu

Penn Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Chrisine Hill-Kayser, MD

215-615-6767christine.hill@pennmedicine.upenn.edu

Kelsey Woodard, MA

9089383329woodardk@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Survivor
  • Adolescents and Young Adults
  • Digital Health Intervention
  • Adaptive Intervention
  • Sequential Multiple Assignment Randomized Trial
  • Long Term Follow Up Care
  • Survivorship Care Plan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-02-18.