530 Participants Needed

Digital Interventions for Cancer Survivors

(REACH:SMART Trial)

Recruiting at 2 trial locations
SK
LS
Overseen ByLisa Schwartz, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests digital tools to help adolescent and young adult survivors of childhood cancer resume regular check-ups. It compares different methods of delivering information, such as written details or simple digital messages (Stage 1 Low Touch Intervention and Stage 1 Written Information), to determine which method more effectively encourages follow-up appointments. Participants will share their experiences through surveys and possibly interviews, aiding researchers in understanding the best ways to support ongoing care. This trial suits individuals aged 15-29 who had cancer before age 22 and have not had a follow-up visit in over 15 months. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance follow-up care for future survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on digital interventions for cancer follow-up care, so it's best to discuss your medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-touch methods, such as providing personalized information or tracking symptoms, are generally safe. These methods help manage health conditions without causing major side effects. Similarly, studies have examined high-touch methods, which involve more personal interaction, for their ability to increase patient involvement in healthcare. These methods have been well-received, with no major safety issues reported. Both approaches aim to help cancer survivors reconnect with their healthcare needs without introducing new health risks.12345

Why are researchers excited about this trial?

Researchers are excited about these digital interventions for cancer survivors because they offer a personalized and adaptive approach to post-treatment care. Unlike traditional methods that might involve fixed schedules and in-person visits, these interventions range from written information to low and high-touch digital tools, responding to each survivor's engagement and needs. This flexibility allows for enhanced accessibility and can be tailored to improve patient engagement, potentially leading to better health outcomes. By integrating digital solutions, the aim is to streamline support and make it more accessible for survivors, possibly transforming the way post-cancer care is delivered.

What evidence suggests that this trial's digital interventions could be effective for cancer survivors?

This trial will explore various digital interventions for cancer survivors. Research has shown that digital tools can benefit those who have survived cancer. Participants in this trial will be assigned to different intervention arms. Studies on low-contact methods, which involve minimal direct interaction, have shown promise in managing patient care and improving health outcomes. For example, one study found that when community health workers led the program, emergency care visits significantly decreased. Providing written information alone also benefits, as it has increased patient satisfaction and involvement in their care. More personalized methods, involving more direct contact, have effectively encouraged the use of preventive health services. Overall, these digital methods can help cancer survivors maintain their follow-up care, potentially leading to better long-term health.678910

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult survivors of childhood cancer. Participants should be interested in re-engaging with long-term follow-up care for their health post-cancer treatment. Specific eligibility criteria are not provided, but typically include age range and past cancer treatment history.

Inclusion Criteria

I am at least 18 years old.
I finished my cancer treatment 2 years ago and was diagnosed 5 years ago.
For Support Person of AYA: U.S. resident
See 9 more

Exclusion Criteria

I am a young adult and have only had surgery for my condition.
I have cognitive issues that may affect my participation.
I am a young adult and have been moved to primary care.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Intervention

Participants receive either a low touch intervention (LTI) with reminder text messages and informational resources or written information (WI) for up to 4 weeks.

4 weeks

Stage 2 Intervention

Participants are re-randomized based on responsiveness to Stage 1. Responders receive either maintenance or a stepped-up condition, while non-responders receive a stepped-up condition, which may include expanded LTI or a high touch intervention (HTI).

16 weeks

Follow-up

Participants are monitored for re-engagement in care and self-management outcomes at 20 weeks (T3) and 36 weeks (T4).

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Stage 1 Low Touch Intervention
  • Stage 1 Written Information
  • Stage 2 High Touch Intervention
  • Stage 2 Low Touch Intervention
  • Stage 2 Written Information
Trial Overview The study tests digital interventions aimed at encouraging AYA cancer survivors to participate in follow-up healthcare. It compares low touch intervention (like brief digital messages) versus written information, assessing which helps more with scheduling/attending appointments and self-management.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Written Intervention + Written Intervention (Responders)Experimental Treatment2 Interventions
Group II: Written Intervention + Low Touch Intervention (Responders)Experimental Treatment2 Interventions
Group III: Written Intervention + Low Touch Intervention (Non-Responders)Experimental Treatment2 Interventions
Group IV: Written Intervention + High Touch Intervention (Non-Responders)Experimental Treatment2 Interventions
Group V: Low Touch Intervention + Low Touch Intervention (Responders)Experimental Treatment2 Interventions
Group VI: Low Touch Intervention + High Touch Intervention (Responders)Experimental Treatment2 Interventions
Group VII: Low Touch Intervention + High Touch Intervention (Non-Responders)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Nationwide Children's Hospital

Collaborator

Trials
354
Recruited
5,228,000+

Citations

Randomized Controlled Pilot Trial of a Low-Touch ...The trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention ...
Low-touch, team-based care for co-morbidity management ...We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data ...
the ONE TEAM randomized controlled trial - BMC Primary CareOutcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of ...
ONE TEAM Study: Onco-Primary Care Networking to ...Results from this intervention will have important implications in the advancement of healthcare delivery for cancer survivors.
Effectiveness of tailored interventions on quality of life in ...This review analyzed tailored interventions for adult cancer survivors across 24 studies and found mixed results regarding their effectiveness in improving QoL.
a randomized control trial of 'high touch' vs. 'high tech' ...The primary outcomes are increased engagement in preventive health services and monitoring for cancer recurrence and treatment-related late ...
High-Touch vs Low-Touch Strategy for Implementing a ...Results Overall, 50 176 patients 18 years and older were seen (33 435 at high-touch and 16 741 at low-touch practices) in the first 6 months ...
Patient engagement strategies in digital health interventions ...Cancer survivors often face challenges related to their mental and physical wellbeing, including higher risks of diseases such as cardiovascular ...
Digital Health Interventions for Adult Patients With Cancer ...Data from full-size RCTs were used to summarize targeted nursing problems and outcomes of digital health interventions. To better understand the outcomes of the ...
Integrating Telehealth to Advance Lung Cancer ScreeningThe goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening ...
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