跳至主要内容
临床试验/NCT07138040
NCT07138040招募中不适用

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

Children's Hospital of Philadelphia6 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
530
试验地点
6
主要终点
Re-Engagement in Care - by T4

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •English proficient
  • •For AYA under age 18, must have a caregiver to provide informed consent

排除标准

  • •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
  • •Inclusion Criteria for Support Person of AYA
  • •Primary caregiver or other support person (e.g. partner, sibling, other caregiver)
  • •At least 18 years old
  • •U.S. resident
  • •English proficient
  • •Exclusion Criteria for Support Person of AYA
  • •No involvement in the AYA's healthcare
  • •AYA Decline support person's participation
  • •Absence of inclusion criteria above

研究组 & 干预措施

Written Intervention + Written Intervention (Responders)

Experimental

Start with written intervention (WI) in stage 1, those who respond (schedule an appointment) in stage 1 continue receiving WI in stage 2 (maintenance).

干预措施: Stage 1 Written Information (Behavioral)

Written Intervention + Written Intervention (Responders)

Experimental

Start with written intervention (WI) in stage 1, those who respond (schedule an appointment) in stage 1 continue receiving WI in stage 2 (maintenance).

干预措施: Stage 2 Written Information (Behavioral)

Written Intervention + Low Touch Intervention (Responders)

Experimental

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.

干预措施: Stage 1 Written Information (Behavioral)

Written Intervention + Low Touch Intervention (Responders)

Experimental

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.

干预措施: Stage 2 Low Touch Intervention (Behavioral)

Written Intervention + Low Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 1 Written Information (Behavioral)

Written Intervention + High Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 1 Written Information (Behavioral)

Written Intervention + High Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 2 High Touch Intervention (Behavioral)

Written Intervention + Low Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 2 Low Touch Intervention (Behavioral)

Low Touch Intervention + Low Touch Intervention (Responders)

Experimental

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).

干预措施: Stage 1 Low Touch Intervention (Behavioral)

Low Touch Intervention + Low Touch Intervention (Responders)

Experimental

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).

干预措施: Stage 2 Low Touch Intervention (Behavioral)

Low Touch Intervention + High Touch Intervention (Responders)

Experimental

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.

干预措施: Stage 1 Low Touch Intervention (Behavioral)

Low Touch Intervention + High Touch Intervention (Responders)

Experimental

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.

干预措施: Stage 2 High Touch Intervention (Behavioral)

Low Touch Intervention + High Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 1 Low Touch Intervention (Behavioral)

Low Touch Intervention + High Touch Intervention (Non-Responders)

Experimental

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.

干预措施: Stage 2 High Touch Intervention (Behavioral)

结局指标

主要结局

Re-Engagement in Care - by T4

时间窗: 36 weeks (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).

次要结局

  • AYA Self-Management (Health Goal Progress)(2 times - at 20 weeks (T3) and 36 weeks (T4))
  • Re-Engagement in Care - by T3(20 weeks (T3))
  • AYA Self-Management (Health Knowledge Inventory)(2 times - at 20 weeks (T3) and 36 weeks (T4))
  • AYA Self-Management (Transition Readiness Questionnaire)(2 times - at 20 weeks (T3) and 36 weeks (T4))
  • AYA Self-Management (Self-Management Skills)(2 times - at 20 weeks (T3) and 36 weeks (T4))
  • AYA Self-Management (Allocation of Treatment Responsibility)(2 times - at 20 weeks (T3) and 36 weeks (T4))
  • AYA Self-Management (Transition Readiness Inventory)(2 times - at 20 weeks (T3) and 36 weeks (T4))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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