Digital Self-Management for Childhood Cancer Survivors

Enrolling by invitation at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Cognitive delay, Non-pediatric cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital self-management and peer mentoring program called Managing Your Health (MYH). It is designed to assist young adult survivors of childhood cancer in managing their ongoing healthcare as they transition from pediatric to adult care systems. The program aims to enhance knowledge of their cancer history, boost confidence in managing healthcare tasks, and address barriers such as financial hardship or distance from care centers. Participants may be suitable if they were diagnosed with childhood cancer at least five years ago, completed treatment two or more years ago, and are currently navigating adult follow-up care. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions tailored for young adult cancer 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 improving self-management skills for young adult survivors of childhood cancer.

What prior data suggests that this digital self-management program is safe for childhood cancer survivors?

Research shows that digital tools like the "Managing Your Health" (MYH) app are generally safe and easy to use. Studies on similar apps for childhood cancer survivors have indicated that these tools are well-received and can improve health management. Users can personalize the app to receive information tailored to their specific needs, enhancing communication with their doctors.

No major negative effects have been reported from using these types of apps. Instead, they assist users in tracking their health and make follow-up care easier to manage. While specific safety data for the MYH app is not yet available, evidence from similar apps suggests it is likely safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Managing Your Health" (MYH) app because it offers a unique digital self-management approach for childhood cancer survivors. Unlike traditional care that often relies on regular in-person visits and educational materials, MYH combines a mobile app with peer mentoring to empower survivors to manage their health independently. This innovative method not only enhances accessibility and convenience but also fosters a supportive community through peer interactions, potentially improving long-term health outcomes for survivors.

What evidence suggests that the "Managing Your Health" program is effective for improving self-management in childhood cancer survivors?

Research has shown that digital self-management and peer mentoring programs, such as the Managing Your Health (MYH) app, can assist young adults who survived childhood cancer. In this trial, participants will either use the MYH app with peer mentoring or receive usual care with educational control. Studies have found that these programs enhance skills for managing personal health and increase healthcare knowledge. This is crucial because better self-management enables survivors to maintain their follow-up care. Improved follow-up care can lead to a better quality of life and overall health. Early findings suggest that combining digital tools with peer support might ease the transition for young survivors managing their health as they move to adult care. ^{6 7 8 9 10}

Who Is on the Research Team?

Kristine Levonyan-Radloff, MS

Principal Investigator

Rutgers Cancer Institute

Are You a Good Fit for This Trial?

This trial is for young adult survivors of childhood cancer who are transitioning from pediatric to adult follow-up care. They should be in need of support to manage their survivorship care and overcome barriers such as poor knowledge, low self-efficacy, and access issues.

Inclusion Criteria

I was diagnosed with cancer as a child or teenager, at least 5 years ago.

At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)

My cancer treatment was at a children's hospital.

Exclusion Criteria

I have a condition that makes it hard for me to manage my health care on my own.

Unable to speak/read English

My cancer type is usually not found in children.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Managing Your Health app and Peer Mentoring Intervention or receive Usual Care + Educational Control

3 months

Baseline, 3 months

Follow-up

Participants are monitored for self-management behaviors, health-related quality of life, and adherence to guideline-concordant survivorship care

9 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Managing Your Health (MYH)

Trial Overview The study evaluates a digital program called 'Managing Your Health' combined with peer mentoring versus usual care plus education. It aims to improve the participants' ability to manage their health after surviving cancer during childhood.

How Is the Trial Designed?

Group I: Managing Your Health (MYH) Experimental Treatment 1 Intervention

The Managing Your Health app + Peer Mentoring Intervention

Group II: Usual Care + Educational Control Active Control 1 Intervention

The Usual Care + Educational Control

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

The LETSGO model, which involves nurse-led consultations and eHealth technology, was well-received by patients, who felt safer and more empowered in managing their health after cancer treatment.

Participants reported increased confidence in recognizing cancer recurrence symptoms and were motivated to enhance their physical activity, although some faced technical issues with the app that need to be addressed before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. Skorstad, M., Vistad, I., Fegran, L., et al.[2022]

A systematic review of eight studies on digital self-management interventions for childhood cancer survivors found that these interventions did not significantly improve health-related quality of life or moderate-to-vigorous physical activity, indicating limited effectiveness.

While the interventions showed a trend towards increasing physical activity over time, the results were not statistically significant, highlighting the need for better-designed studies to assess their true impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. Hong, HC., Min, A., Kim, YM.[2021]

Digital health interventions are generally well-received by pediatric cancer survivors, providing benefits such as self-awareness, social connection, and empowerment, based on a systematic review of 16 qualitative studies.

However, users also face challenges related to program content, technology, and personal usage, highlighting the need for tailored interventions to enhance their effectiveness and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. Cheng, L., Liu, F., Mao, X., et al.[2022]

Self-management education programs (SMEPs) can significantly improve self-efficacy, health knowledge, and health behaviors in chronic disease populations, but very few are tailored for adolescent and young adult (AYA) survivors of childhood cancer, who face unique health risks and challenges.

Mobile health (mHealth) applications are identified as a promising method for delivering self-management education to AYA cancer survivors, but these interventions need thorough evaluation to ensure they effectively support survivor-focused care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Literature Review and Environmental Scan of Self-management Education Programs for Adolescent and Young Adult Survivors of Childhood Cancer. Kobe, CM., Turcotte, LM., Sadak, KT.[2023]

In a pilot study involving 26 female childhood cancer survivors, the Health Storylines mHealth app was used frequently, with some participants accessing it up to 902 times, but overall, there were no statistically significant improvements in self-efficacy, perceived illness, or health-related quality of life after 3 or 6 months of use.

The study highlighted that while the app's mental health component was utilized by all participants, the effectiveness varied significantly between high and low users, suggesting that further research is needed to identify which individuals benefit most from such mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. Cantrell, MA., Ruble, K., Mensinger, J., et al.[2022]

About 23.7% of young adult cancer survivors and their parents registered for the ePHR, Cancer SurvivorLinkTM, and 38% of those registrants used it meaningfully, indicating a significant but selective engagement with the tool.

Young adult survivors transitioning to adult care were more likely to use the ePHR meaningfully, and using SurvivorLink was linked to a higher likelihood of attending annual follow-up visits, suggesting it may enhance care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful Use of an Electronic Personal Health Record (ePHR) among Pediatric Cancer Survivors. Williamson, RS., Cherven, BO., Gilleland Marchak, J., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06763770

Digital Self-Management and Peer Mentoring Intervention This study tests how helpful a digital self-management and peer mentoring program is to young adult survivors of childhood cancer to improve their ability ...

2. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10715644&term=CA282147

Division of Cancer Control & Population Sciences - Grant Details The goal of this project is to evaluate the efficacy of Managing Your Health (app + peer mentoring) compared with educational control in a two-arm randomized ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9386586/

Development of a Self-management and Peer-Mentoring ... This study aims to identify the content of a self-management intervention to improve transition readiness among adolescent and young adult (AYA) survivors.

4. researchgate.net researchgate.net/publication/388526702_A_randomized_feasibility_trial_of_Managing_Your_Health_a_self-management_and_peer_mentoring_intervention_for_young_adult_survivors_of_childhood_cancer

a self-management and peer mentoring intervention for ... The goal of this study was to evaluate the feasibility and acceptability of the “Managing Your Health” self-management and peer mentoring ...

5. ctv.veeva.com ctv.veeva.com/study/digital-self-management-and-peer-mentoring-intervention

Digital Self-Management and Peer Mentoring Intervention This study tests how helpful a digital self-management and peer mentoring program is to young adult survivors of childhood cancer to improve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460307/

mHealth Apps in the Digital Marketplace for Pediatric ... This study reports a systematic search and analysis of mHealth apps available on the Apple App (iOS) and Google Play (Android) stores designed for pediatric ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772628221000108

eHealth tools for childhood cancer survivorship care eHealth tools appear acceptable and may help to improve the management of late effects for childhood cancer survivors and assist their GPs to coordinate their ...

8. gavinpublishers.com gavinpublishers.com/article/view/a-mobile-application-for-childhood-cancer-survivorship-care:-a-cross-sectional-survey-study

A Mobile Application for Childhood Cancer Survivorship Care Survivors can update their preferences within an app to reflect their individualized informational needs as well as the mode of delivery of such messages (Table ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132021/

A Mobile Self-Management App (CanSelfMan) for Children ... A self-management app that provides access to reliable information to improve communication between health care providers and children with cancer.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03945032

Study Details | NCT03945032 | TICOP Mobile App and E ... This study aims to develop a mobile App (named "TICOP") for parents of a childhood cancer survivor and an E-Platform for health professionals which work in ...