AzTrials
AzTrials

CancerREACH:SMARTNCT07138040

Re-Engaging AYA Survivors in Cancer-Related Healthcare

A study testing Stage 1 Written Information, Stage 1 Low Touch Intervention and Stage 2 Written Information in people with Cancer, run by Children's Hospital of Philadelphia at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 15 to 29 years
Conditions the study is for
Cancer
What is being tested?
Stage 1 Written Information, Stage 1 Low Touch Intervention and Stage 2 Written Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
3 sitesUnited States
Study dates
1 Aug 2025to 30 Apr 2028
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 15 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 15-29 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
Show all 12Show fewer
  • English proficient
  • For AYA under age 18, must have a caregiver to provide informed consent
  • Primary caregiver or other support person (e.g. partner, sibling, other caregiver)
  • At least 18 years old
  • U.S. resident
  • English proficient

Who cannot join

  • 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
  • Absence of inclusion criteria above
Show all 9Show fewer
  • No involvement in the AYA's healthcare
  • AYA Decline support person's participation
  • Absence of inclusion criteria above

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Schwartz, PhD contact

(267) 426-0355

SCHWARTZL@chop.edu

Sara King-Dowling, PhD contact

(267) 426-5562

kingdowlis@chop.edu

United States3 sites, 3 recruiting
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Ahna Pai, PhD, 614-938-1601, ahna.pai@nationwidechildrens.org

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

    Recruiting
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Lisa Schwartz, PhD, 267-426-0355, SCHWARTZL@chop.edu

    Sara King-Dowling, PhD, (267) 426-5562, kingdowlis@chop.edu

    Recruiting
  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

    Chrisine Hill-Kayser, MD, 215-615-6767, christine.hill@pennmedicine.upenn.edu

    Kelsey Woodard, MA, 9089383329, woodardk@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: Re-Engaging AYA Survivors in Cancer-Related Healthcare: A Sequential Multiple Assignment Randomized Trial

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).

Read the detailed description

Over 80% of children diagnosed with cancer become long-term survivors; however, 70% develop chronic or life-threatening late effects from treatment, and these often emerge during young adulthood. Guidelines recommend annual long-term follow-up care (LTFU) to manage and monitor for late effects, recurrence, or new cancer(s). Yet, as risk for late effects increases in young adulthood and survivors transition into adult-focused care, engagement in care plummets. Disengagement from LTFU leaves adolescent and young adult survivors (AYA) vulnerable to delayed or poorly managed diagnoses and relates to lower knowledge and self-management abilities. Thus, interventions targeting re-engagement of AYA are critical for this vulnerable population. The REACH (Re-Engaging AYA survivors in Cancer-related Healthcare) study will test a low touch intervention (LTI), consisting of reminder "nudge" text messages and informational resources for up to 4 weeks compared to an enhanced usual care group that will receive written information (WI) only.

In Stage 2, AYA will be re-randomized based on responsiveness to Stage 1 (i.e., whether or not they made an appointment) into 16 weeks of intervention. Responders will either be re-randomized to receive a continued intervention (maintenance) or a stepped-up condition, while non-responders will only receive a stepped-up condition. Step-up may include expanded LTI (more text messages) or a high touch intervention (HTI). The HTI includes text messages and digital resources, including a personalized survivorship care plan (SCP), and a mobile-friendly platform with information tailored to variables such as barriers to care, treatment history and recommendations, and a personal health goal. Additionally, social worker and/or nurse support will be available to help overcome barriers (e.g., access care).

The intervention options in Stage 2 are intended to enhance self-management beyond simply attending LTFU in order to sustain long-term engagement. Outcomes are measured after Stage 1 (T2), Stage 2 (T3) and at 36 weeks (T4).

It is expected that those who start with LTI versus WI will be more likely to attend a LTFU appointment by T4. For Stage 2, those who receive the stepped-up condition compared to those with maintenance, and those who received HTI compared to LTI, will be more likely to attend an appointment by T4. Attending an appointment by T3 and indices of self-management are secondary outcomes. The study team will assess moderators of intervention outcomes, intervention engagement, acceptability, feasibility, and cost. Qualitative interviews will assess multilevel barriers and facilitators of future implementation with stakeholders (AYA, parents/supports, providers, administrators). This trial aims to promote optimal engagement in LTFU and self-management for AYA survivors, improving outcomes and reducing disparities. For Stage 2, those who receive the stepped-up condition compared to those with maintenance, and those who received HTI compared to LTI, will be more likely to attend an appointment by T4.

Conditions
Cancer
Being tested
Stage 1 Written Information, Stage 1 Low Touch Intervention, Stage 2 Written Information, Stage 2 Low Touch Intervention, Stage 2 High Touch Intervention
Keywords
Survivor, Adolescents and Young Adults, Digital Health Intervention, Adaptive Intervention, Sequential Multiple Assignment Randomized Trial, Long Term Follow Up Care, Survivorship Care Plan
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stage 1 Written InformationBehavioural

    Also called S1 WI

    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 InterventionBehavioural

    Also called S1 LTI

    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 InformationBehavioural

    Also called S2 WI

    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 InterventionBehavioural

    Also called S2 LTI

    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 InterventionBehavioural

    Also called S2 HTI, HTI

    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 groups in NCT07138040
Study groupRoleWhat they receive
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).
Receives: Behavioral: Stage 1 Written Information; Behavioral: Stage 2 Written Information
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.
Receives: Behavioral: Stage 1 Written Information; Behavioral: Stage 2 Low Touch Intervention
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.
Receives: Behavioral: Stage 1 Written Information; Behavioral: Stage 2 Low Touch Intervention
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.
Receives: Behavioral: Stage 1 Written Information; Behavioral: Stage 2 High Touch Intervention
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).
Receives: Behavioral: Stage 1 Low Touch Intervention; Behavioral: Stage 2 Low Touch Intervention
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.
Receives: Behavioral: Stage 1 Low Touch Intervention; Behavioral: Stage 2 High Touch Intervention
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.
Receives: Behavioral: Stage 1 Low Touch Intervention; Behavioral: Stage 2 High Touch Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 36 weeks (T4)

Secondary outcomes (7)
  1. Re-Engagement in Care - by T3

    Percentage of participants who re-engage in care (attend a LTFU appointment) by T3 as measured by electronic health record (EHR) review. If attendance is not viewable in EHR, it will be ascertained by self-report (yes/no).

    Measured: 20 weeks (T3)

  2. AYA Self-Management (Health Knowledge Inventory)

    Measured via self-reported participant questionnaire. For the Health Knowledge inventory (28 items), a total percentage correct score will be reported 0-100%, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

  3. AYA Self-Management (Transition Readiness Questionnaire)

    Measured via self-reported participant questionnaire. For the Transition Readiness Assessment Questionnaire (20 items), a total average score will be reported ranging from 1-5, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

  4. AYA Self-Management (Self-Management Skills)

    Measured via self-reported participant questionnaire. For the Self-management Skills Scale (15 items), a total percentage score will be reported ranging from 0-100%, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

  5. AYA Self-Management (Health Goal Progress)

    Measured via self-reported participant questionnaire. For the Health Goal Progress (5 items), a total score will be reported ranging from 5-24, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

  6. AYA Self-Management (Allocation of Treatment Responsibility)

    Measured via self-reported participant questionnaire. For the Allocation of treatment responsibility, clinic appointment subscale (5 items), a total score will be reported ranging from 5-20, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

  7. AYA Self-Management (Transition Readiness Inventory)

    Measured via self-reported participant questionnaire. For the Transition Readiness Inventory (28 items), a total average score will be reported ranging from 1-5, with higher scores representing greater self-management.

    Measured: 2 times - at 20 weeks (T3) and 36 weeks (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential Multiple Assignment Randomized Trial with 2 stages of randomization
Masking
None (open label)
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07138040
Sponsor's protocol ID
IRB 22-020668
Other IDs
R01CA273328
Acronym
REACH:SMART
Status last verified
Feb 2026
First submitted
15 Aug 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Stage 1 Written Information, Stage 1 Low Touch Intervention and Stage 2 Written Information in people with Cancer, run by Children's Hospital of Philadelphia at 3 sites 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 12 inclusion and 9 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Lisa Schwartz, PhD ((267) 426-0355, SCHWARTZL@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Re-Engagement in Care - by T4 (time frame: 36 weeks (T4)). 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 18 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in