Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
530 participants
INTERVENTIONAL
2025-08-01
2028-04-30
Brief Summary
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* 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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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).
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 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.
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.
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 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.
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.
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 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.
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.
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 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.
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).
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 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.
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.
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 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.
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.
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 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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
1. No involvement in the AYA's healthcare
2. AYA Decline support person's participation
15 Years
29 Years
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
University of Pennsylvania
OTHER
National Cancer Institute (NCI)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB 22-020668
Identifier Type: -
Identifier Source: org_study_id
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